Pfizer

I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.

Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold

No symptoms or pain with initial injection. I came home about 2 hours after the injection and took one 200mg ibuprofen and one 500mg acetaminophen and put an ice pack on the site briefly. Later that afternoon I developed pain at the injection site that progressively got worse over the course of the evening so bad that I could not raise my left arm of touch the site. I put an ice pack on again and that night I slept with a heating pad on. I would rate the pain 8/10. When I woke the next day the pain was still there, but not as severe. I got in the shower and let the hot water beat on the injection site and that seems to help a lot. The pain gradually lessened over the course of the day to a 2/10. By the following day (3rd day post injection) the pain had completely subsided. There was no redness or swelling at the site and I did not have any other symptoms other than the intense injection site pain.

* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight

Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.

hypertension, dizziness - occurred ~15 minutes after her first dose; first BP was 166/81, second dose was 158/84; Taken to ED; outcome unknown

Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021 MRN: 3274958   Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020   PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours.     ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness       Objective   Vitals Vitals:   01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38   Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm     APRN Electronically Signed 1/6/2021 12:45 PM    

19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue

INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.

Rec'd Covid vaccine after 15 min obs stated she felt "swooney, dizzy, like" BP 168/86 HR 68 states she has a hx of HTN she usually runs 120's/70's Monitored for another 25 min BP ranging 157/87 - 173/86, prior to leaving states she was not feeling dizzy anymore BP 164/88 HR 69, and wanted to go back to work. Could not find anyone to take care of her patients and was concerned. Coworker states they would monitor her.

Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.

Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20

dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

Dizziness with first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. Monitored vitals, which remained stable. Patient thought it was more of a mental effect because of something that a friend told her about the vaccine. Patient was reassured and when she felt better, was released back to work.

very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.

dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath

Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest

the patient began to experience dizziness and flushing; the patient began to experience dizziness and flushing; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The female patient who was seen at (Clinic name) today on 06Jan2021 for her second dose of the COVID 19 vaccination. During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing on 06Jan2021. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness. The outcome of the events was unknown. This case was reported as non-serious. No follow-up attempts are possible. No further information is expected.

developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report to work the following day, symptoms then resolved.

Employee states she felt dizzy, lightheaded, palpitations and like her blood pressure was elevated. Vitals signs WNL, monitored for 60 minutes.

Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.

1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was briefly dizzy but only for a few seconds at most. 2) By the time I reached my car, I had developed a mild headache which lasted until around noon the next day. The headache was not severe. 3) Shoulder that received the shot was sore for about two days.

Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.

patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.

limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;

Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.

Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening

WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH

Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours

Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her right hand was pale. + tingling. Brought to be evaluated by EMT.

Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.

The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.

Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.

Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.

Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.

Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92

Patient complaint of dizziness. Vitals taken: BP 132/60, temp 97.3, heart rate 68, oxygen saturation 98%. Patient monitored for 30 minutes. Patient stated dizziness subsiding.

Patient received Pfizer vaccine at 1310. At 1340, she complained of dizziness. Vitals: B/P 132/60, temp 97.3, heart rate 68, oxygen saturation 98%. Patient alert and oriented. 1405 patient stated dizziness is subsiding.

First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

26th 0130-can't move, all joints bones-Can't get out of bed. No eating. Poor voiced quality. She's been vomiting. When I asked her the Lot# and manufacturer-she said-stop yelling- don't get frustrated-began to cry-I softy asked the question again Lot# and Manufacturer. Told to go see her PCM.

arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.

Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.

day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......

Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.

nausea and dizziness/dizziness and nausea went pretty extreme; nausea and dizziness/dizziness and nausea went pretty extreme; This is a spontaneous report from a contactable consumer (husband of patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Jan2021, 2 days after vaccination, patient experienced nausea and dizziness, that went away. Until yesterday, 19Jan2021, her dizziness and nausea went pretty extreme. She was scheduled for a second dose in about 2 weeks, on 09Feb2021. Outcome of events was not recovered. Information on the lot/batch number has been requested.

Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.

minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.

light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks. On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.

1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'

Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.

12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.

Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.

Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.

lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.

This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation . Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before). Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation. Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00 temperature of 100.6, arthralgias and myalgias, dizziness. Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness, Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias was recovering.

This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no concomitant medications. The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), other route on the right arm at the age of 60 years, on 02Feb2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. Concomitant medication included simvastatin (SIMVASTATIN), duloxetine (DULOXETINE), raloxifene (RALOXIFENE), chlorthalidone (CHLORTHALIDONE), levothyroxine (LEVOTHYROXINE) , calcium (CALCIUM), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), folic acid (FOLIC ACID), fish oil (FISH OIL), vitamin b12 nos (VITAMIN B12 NOS) , calcium carbonate, colecalciferol (VITAMIN D 2000) and Tumeric. The patient had the first dose of vaccine on 12Jan2021. After the 2nd shot, the patient's arm didn't get heavy, just felt a weakness going from shoulders down to hands on Feb2021. She couldn't move or feel them for 15 min. Slowly she could move her fingers then hands then lift arms. The next day her brain felt kind of fuzzy and still a little "off kilter" on 2nd day (Feb2021). She did not have any anxiety about either shot, even with what happened with the first one. The outcome of the events was recovering.

During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins

As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. I see that COVID-19 biofire came back positive. In light of this, COVID myelopathy is on the differential

About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed. BP was high but otherwise vital signs within normal limits. Symptoms resolved.

Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2 97% on intial check. She also reported a right frontal headache 5/10. Moved to cot to lie down, VS re-checked. Dizziness did not resolve with lying down. BP remained elevated as well. Once lying down, patient also reported "heaviness" in chest. A nurse remained with patient throughout entire incident and VS assessed frequently. After about 45 minutes, patient still reported HA, dizziness. Patient reported chest heaviness had resolved, but BP and dizziness did not resolve. Discussed calling EMS with patient, she agreed to allow us to call EMS. She was transported to local hospital by EMS at approximately 11:30am.

IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever

started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her blood sugar, and her blood sugar was high at 146.; This is a spontaneous report from a contactable consumer (patient's daughter). A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the right arm on 28Jan2021at 09:30 (at the age of 60-years-old) as a SINGLE DOSE for covid-19 immunisation . Medical history included breast cancer female from 17Feb2019 (taking medicine for the breast cancer for 2 years), Cardiac disorder from an unknown date (problems with her heart about 2 weeks ago, and had to have her heart examined), and Prediabetes Concomitant medication(s) include takes medication for breast cancer and prediabetes. No other vaccines were given within 4 weeks No Additional Vaccines were administered on Same Date of the Pfizer Suspect. On 28Jan2021, The patient experienced started to feel dizzy after getting the first dose of the COVID-19 Vaccine today and just checked her blood sugar, and her blood sugar was high at 146. No Physician office visit and No Emergency room visit required due to the events. Reporter stated her mother is feeling better now. Patient checked her blood pressure and it was 127/72. The patient underwent lab tests and procedures which included blood glucose: High 146 on 28Jan2021; blood pressure measurement: 127/72 on 28Jan2021, cardiac stress test: unknown results on an unknown date, heart resistance test: unknown result on an unknown date. Caller asked what Pfizer recommends for the dizziness. The clinical outcome of the event dizzy was recovering which blood glucose high was unknown Information on the lot number has been requested.

Dizziness, Numbness of tongue and lightheadedness. 50mg PO Benadril. Monitored for 30 minutes. All symptoms resolved. No further intervention required. Patiient released to home with spouse.

Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.

SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEAT. DIZZINESS FOR APPROX 4 DAYS, HEADACHE FOR APPROX 4 DAYS

Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"

10 minutes after getting the shot I felt like I was going to pass out, I felt like my heart was beating slowly, I was breathing but felt like I couldn't get a good breath. It lasted about 5 minutes. I had the same reaction on methotrexate, which I quit taking.

Approximately 15 minutes after the vaccine was administered, the patient reported feeling lightheaded and tingling sensation of the face; patient also stated that she "feels like tongue is swollen." Patient vital signs were taken by EMS on site. Vital signs were within normal limits.

Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the day progressed the pain increased substantially into my shoulder. It then started to hurt on the left side of my neck. I took Tylenol before bed, 500 mg is all I can take. This pain kept me awake all night and this morning I am not able to lift my arm up or down or sideways without pain, quite a bit of pain. Today is Sunday and I do not plan to seek medical care unless it continues to worsen. I will probably talk with my medical provider tomorrow if this continues.

Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til 3:30 next day(Friday March 5)Slept all day,made appointment with Primary, took dosages of Ibuprofen

On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.

I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.

Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.

Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.

Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute. Remained sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.

On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.

I developed vertigo a week after receiving vaccine. Had a second instance a week later. Vertigo developed again within a week after receiving second dose of vaccine and I had a second instance two days after the first .

Tingling/numbness started in feet and then worked it?s way to the top of my head. The tingling/numbness lasted about 10 hours and gradually diminished from my feet up to my head. About 2 hours after the tingling/numbness started I felt my blood pressure or blood sugar start to fluctuate up and down for about 2 hours. I stayed in bed for this time period. I felt light-headed and scared. After about two hours, I felt stable enough to get out of bed and ate some food and drank some liquids. The numbing/tingling sensation seemed concentrated around my head for hours. I couldn?t really focus on anything. It felt like when your foot falls asleep. I felt as if I was having a neurological reaction because of the weird tingling numbness sensation. It felt like my nerve endings were firing all over; like having the chills without being cold. Although the biggest event was on 2/28, I felt the tingling ing/numbness in my arms on and off for at least another week. I?m scared to get the 2nd dose.

Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9

Patient presents with feeling lightheaded after she got the second dose of her Pfizer vaccine about half an hour ago. She is brought over here by staff at the vaccine clinic. She continues to have some shakiness. She denies any pain or shortness of breath. Symptoms are worse when she is sitting up. She has had syncopal episode in the past. Denies any chest pain.

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

My tongue swelled slightly and the right side of it became numb. This lasted for 30 minutes. If it had gotten worse I would have gone to a hospital but it went away. Also, starting around 8 PM on Thursday and lasting until Saturday evening, my hips and lower back were extremely stiff and achy.

Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache.

experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s

Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also started shaking uncontrollably particularly hands and arms. Vaccine administrator was immediately notified and they summoned the closest EMT. Emergency Services took my BO and pulse oximeter. A few minutes after the start of the symptoms. They explained that since my HR was at 84, BP was 110/68 and oxygen saturation was at 98% and I wasn't having difficulty breathing that I was not having an allergic reaction to the vaccine but a parasympathetic response instead. They sat with me until the shaking stopped approximately 15minutes later.

my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.

After receiving her vaccine, client stated she felt lightheaded and anxious. Vital signs obtained by EMS BP 177/106, HR 83, O2 sat 99%. Client stated she feels better. Client discharged home.

Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.

Patient reports having a history of anxiety. Stayed for 15 minutes, then went up to her apt. She came back down to report that she was having pain in her right breast (hx of Cancer in it) then it radiated to her right side down to her pelvic region. She reported feeling woozy/dizzy. She did not lose conciousness. HR was 80 regular, BP 164/92, lungs clear.

03/15/21 @3:30AM awoke with significant headache and vertigo, room spinning around me, could not lay flat. By about 7:00AM vertigo stopped, had HA, dizziness with loss of balance. Ibuprofen 400mg q3-4 hrs, sudafed 30mg q4 hrs. Continued unchanged x 48 hrs. Today, 03/17/21, HA, dizziness, loss of balance somewhat improved, still taking ibuprofen 400mg every 4-5 hrs . Had covid in January 2021 with HA and vertigo as presenting symptoms.

Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earlier but better now. . B/P @ 141/92 02 Sat. @ 96-99%. Doctor evaluated pt rechecked B/P @ 100/50 02 @ 96-99%. After evaluation pt states less wekness to body. Pt keep in Obsrvation area.Pt felt better and wants to go home Doctor notifed. Instructions given to pt to go to Urgent care or E.R. @ Medical Center if sympyoms worsen and return tomorrow if s/s continue. Can be discharged. Pt accompanied to vehicle to daughter. Instruction given to daughter verbalized all discussed.

Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe headache and nausea. She was hemodynamically stable no signs of any allergic reaction. There are concerns her V-P shunt is not working properly. After lying in a recumbent position for 30+ minutes headache worsened. We elected to transport to ER, via ambulance so she was recumbent during transport.

Pt. at the observation area felt a heat flash and dizzy, paramedics assessed pt. Once pt. was feeling better, paramedics released her to home.

After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness resolved; slight nausea when leaving - felt much better

Week after receiving vaccine: Extreme bout of dizziness Aggravated existing tinnitus (left ear only) Appeared to be further hearing loss in left ear Sensations in face

Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Client c/o light headed feeling immediately after receiving vaccine. Client denies any other symptoms. Client seen and assessed by EMT and assessments are: BP 173/78, HR 94, O2 96%, Client verbalized a decrease in symptom and cleared to go home by EMT. Client advised to seek medical attention if symptoms worsened and she verbalized understanding.

Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.

Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone

3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something. Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid. Was discharged with prescription for Epi Pen, Zyrtec, and Pepcid. Still have rash and hives but not as extensive, comes and goes.

swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.

nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days), sore injection site (1 day)

8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.

After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness resolved. Slight nausea when leaving felt much better. VS 168/90; 73; 97%SaO2

By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.

I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.

Patient was walking to the bathroom when she became dizzy. Patient provided with chair on her walk to the bathroom and made aware that we needed her to be stable before getting up again. Patient took a 5 minute rest and felt better. Patient guided to the bathroom but once she came out of the bathroom she became dizzy again. Patient was provided with a chair again but started to become frantic so we provided her with a cot and laid her down but patient started to become very short of breathe. Medics called and provided with hand off.

Shortness of breath, dizziness, chest pressure, started about 5 minutes after administration of vaccine.

At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.

Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.

Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache

As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.

Patient complained of feeling dizzy and hands tingling. One set of vital signs taken but patient refused a second set of vital signs. Patient felt fine after speaking with the medical doctor and went home.

Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complaining of tingling in tongue/lips. Patient was evaluated and given diphenhydramine and famotidine. Symptoms were improved and patient was discharged. Patient returned to emergency department approximately 4 hours later with general weakness/lightheadedness, rapid heartbeat, feeling of throat closing. Solu-medrol and IV fluids were administered. Patient felt much better and was discharged with a prescription for oral prednisone. **Note, this information was reported from patient's primary care office. An event have already been reported to VAERS for this patient by Hospital**

After I left the facility, driving home I notice that my back was starting to hurt, so I turned on the heat on my back . When I got home, I had difficulty getting out of my car. I sat in a chair and within the next few minutes I was not able to stand. My husband had to come help me get up and stand, there was pain across my lower back like pin needles and up part of my spine. I took Motrin and it helped it subside somewhat not much. The second day it continued but later started to ease a little but I was not able to walk upright. Third day, 3/24, it is starting to ease up and I am able to walk upright, there is still discomfort. I have contacted my physician to report the issue.

She has shoulder injury related to vaccine administration with decreased range of motion of shoulder, pain at deltoid and pain with overhead activities that persists, albeit some improved, for 2.5 months post vaccination

The injection was in the shoulder. Pain began less than one day later. I waited for the pain to resolve. It has not. My shoulder is still sore. The pain is getting progressively worse and it now hurts to comb my hair, it hurts to raise my arm to put dishes in the cabinet, and it is hard to carry lift and carry objects of 8 ounces more. This pain also make it difficult to sleep through the night.

seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.

things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.

Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.

Patient received 2nd Pfizer COVID vaccine today; completed 15 min RN observation; however, described to nursing staff she was starting for feel dizziness, tingling of hands, feet and " sudden odd, metallic taste" in mouth. A/O x 4 VS stable; reports dizziness, tingling to hand and feet bilaterally. Patient was assisted w/transfer from chair to wheelchair and transported to UC department accompanied safely by RN. RN/COM advised of incident.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

patient states a few seconds after receiving the vaccine she was light headed, and had a low grade headache. Later on that evening she began to have 1/10 central abdominal pain. C/o coughing spasm in the middle of the night that went away after a few minutes. Also c/o moderate fatigue.

felt nausea and dizziness on day of vaccine. 2-3 days after sore throat, hard to swallow, 5 days after vaccine lost voice and/or voice change. no fever at any time

Felt fine after injection; waited 15 minutes felt fine. Got up at 4 am to assist my mom in using the bathroom and everything was spinning in the room. I sat down on floor for about a minute and thought it passed, stood up and took two steps, and from what I?m told I went flat down on the ground without trying to even break my fall. I was out cold. Taken to hospital where I had four ct scans, numerous xrays done; all okay minus pulled muscles/ligaments and possibly some fractures in my foot. I had surgery on it in January and they couldn?t tell if it was old or new fractures.

Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and quad. It only affected this site. It went away but I found it odd. I got the usual bit of nausea, wooziness, fatigue and sore arm, but those were expected

Potential hearing loss; Dizziness about one week after receiving which lasted about 3 hours; More intense tinnitus symptoms than usual; More intense tinnitus symptoms than usual; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL9629), via an unspecified route of administration, administered in left arm on 08Mar2021 13:00 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a pharmacy/drug store. No other vaccine in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Medical history included tinnitus, allergy to PCN and "Thygeson's Disease". Concomitant medication included ciclosporin (RESTASIS). The reported adverse events were dizziness about one week after receiving which lasted about 3 hours; more intense tinnitus symptoms than usual and potential hearing loss, all on 15Mar2021 at 17:00. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events. The outcome of the events was recovering.

Patient administered 1st dose Pfizer COVID 19 vaccination. Approximately 10 min after receiving vaccination, patient became dizzy and tremulous. Tremors increased for left arm to more generalized and more significant. Denied shortness of breath. ED and on site physician notified and patient transferred to ED for further treatment. .

Pain at injection site, extreme back and body aches, headache, dizziness, low grade fever. Ibuprofen & Acetaminophen As of 4:00pm on following day of injection, reactive symptoms still occurring...

dizziness, ear fullness after 10 minutes from getting vaccine. 125/79,76,98% drank some water and stated felt better, refused transport to ED

3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.

Site soreness immediately following vaccine which dissipated quickly. HOWEVER, 4 days AFTER vaccine experienced extreme vertigo, dizziness, nausea which required an ER visit. Side effects still lingering next day.

Patient received vaccine and in the waiting area after waiting for 6 minutes began to complain of lightheadedness. She stated that she has had a migraine for a few days. Patient's BP readings were 196/110, 195/107, 191/114. EMS was contacted and came to assess the patient. Her BP was 190/120 . She did not go to the hospital but was strongly advised to follow up with her doctor.

Feels dizzy but thinks it may be anxiety. No other signs or symptoms. Informed to seek medical advice if any further problems.

Patient stated she felt lightheaded. Vital signs taken and within normal range. Patient felt well after 17 minutes and left the facility.

BP 100/100 mmHg, HR 72 History of Orofacial granulomatosis, neurofibromatosis type 2 and Sjogren's and trigeminal neuralgia Around 10 minutes after receiving the vaccine developed tinnitus, severe vertigo and left sided facial pain in typical character and pattern of her trigeminal neuralgia and then at 14:24 some lower lip swelling typical of what she develops with her orofacial granulomatosis patient took 1200 mg of her own IR gabapentin. Symptoms progressively worsened.

History of orofacial granulomatosis, neurofibromatosis type 2, Sjogren's and trigeminal neuralgia. Around 10 minutes after reaching vaccine developed tinnitus, severe vertigo and left sided facial pain in typical character and pattern of her trigeminal neuralgia and then at 14:24 some lower lip swelling typical of what she develops with her orofacial granulomatosis patient took 1200 mg of her own IR gabapentin. Symptoms progressively worsened

Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported vitals from ER BP=107/70, Liver tests were off due to dehydrated per ER , had fever ,sweats then chills and Headache followed by fatigue for a few days. Patient did notify her PCP

On Saturday, April 3, 2021 clientt received her first dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 2:00pm. After vaccine was administered, client was to wait in the Observaton Area for 30 minutes due to Penicillin and sulfa drug allergy. At 2:09pm, client walked up to EMT and stated she was "feeling light-headed." Client was advised to sit in the anti-gravity chair and was given a bottle of water. Upon assessment by EMTs, client's last meal was at 12:30pm. Client also stated to EMTs she felt light-headed right after receiving the vaccine. At 2:13pm, the client stated the back of her neck felt "a little tight" and stated she had a headache. At 2:15pm vitals were taken: BP: 130/76, Hr: 57, RR: 15, O2 sat: 97%. Lead PHN was notified and advised client to be watched for an additional 30 minutes. Vitals at 2:20pm: BP: 128/78, HR: 59, O2 sat: 98%. Vitals at 2:25pm: BP: 128/70, HR: 59, O2 sat: 97%. At approximately 2:40pm, client stated her light-headedness and tightness on the back of her neck completely subsided. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client was able to ambulate with EMTs to her car with a steady gait at approximately 3pm.

Tachycardia, hypertensive episode within 2 minutes. Diarrhea, flushing, and palpitations about an hour later, and later that afternoon. Diarrhea, dizziness, fatigue, and palpitations the afternoon of 4/2/2021.

Pt reported being sweaty, dizzy and fatigued about 5 minutes after receiving vaccine. Heart rate 80, BP 110/78 resp rate 22 SPO2 98%. Pt felt better within 15 minutes and was asking to go home. Was allowed to leave and advised if any further issues, she should go to ED

12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.

Fainted morning after 2nd Pfizer shot and needed 8 staples for gash on back of my head. Second day after shot I woke up with 102 fever and general malice.

Morning of April 4th: Nauseous, Fever (100 F), High Blood Sugars -Took 2 Tylenol pills - Felt better early afternoon Late Afternoon April 4th: Dizzy, Nauseous, Light Headed, Collapsed and was unconscious for 2ish minutes - Called 911 -> Medics ran heart and bp tests which were all normal and did not consent to go to hospital Evening April 4th: Chills, Fever spiked to 100F, Nauseous, Light headed -Took 2 Tylenol pills - Did not take Ciprofloxacin evening dose Morning April 5th: Fever hovering around 100F, more color in face and up and moving around -Reported incident to doctor & pharmacist where Ciprofloxacin came from - Pharmacist contact information

soreness extreme dizziness 4 days after with vomiting , unable to keep food down. headaches still vomiting second day with no fever but on and off chills

Allergic reaction . Tremors. Ataxia. Spent 36 hours in ER with violent tremors, the tremors lasted 4 days follow by burning and painfully legs especially, in calf area made walking painful. As of this report legs still painful.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium

appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.

I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.

DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIRIUM AND HYPERTENSIVE EMERGENCY REQUIRING ICU HOSPITALIZATION

Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.

possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.

Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed. She has a history of low blood pressure, never high. They did an angiogram that came back normal and an MRI as well. They have been unable to find a cause of the stroke at this time. She was in ICU for four days then Neuro PCU for about 4 days and now she is in inpatient rehab. She is currently learning to walk and has weakness on her whole left side. Vision issues. And motor control issues of the left arm. The stroke came on very sudden and she felt fine before her sudden ?worst migraine ever?. Luckily my brother was with her and took her to get help straight away before she became unconscious.

her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.

This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.

Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient was working in the traffic area of the parking lot. The patient was exiting the area after the 15 min observation period. She reported no symptoms or complications prior to leaving the area and no usual behavior was noted at this time. Patient was accompanied by her husband and son. Near the parking lot the patient was witnessed losing consciousness and falling to the ground. Patient immediately assisted the patient and also called for assistance. I was notified immediately and myself, the paramedics on sight, and NP responded to the patient incident. The patient was diaphoretic and had abnormal vital signs that were repeated multiple times. The set I obtained were 117 heart rate, 99% oxygen on room air, 167/94, 225/112, both taken lying down. Patient complained of severe headache, blurry vision, tinnitus, and dizziness over the past 2 days prior to days. Patient reports having only one medical condition, psoriasis, and takes a cream for it, but also reports she has not seen a doctor in "many years". No stroke symptoms were observed.

High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Vertigo, ongoing since 04/25/21 and continuing today. Severity has lessened, but I still experience it a few times daily.

This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.

Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation. Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago. No follow-up attempts are needed. No further information is expected.

I have been sick; couldn't eat anything down; lost consciousness; Trigeminal neuralgia attack; Trigeminal neuralgia attack; massive vertigo attack; eye was so swollen; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Apr2021 (at the age of 60-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history included trigeminal neuralgia, head injury, pulmonary problems, severe migraine and tumor in lymph node. Concomitant medications were not reported. On 09Apr2021, the patient lost consciousness; in Apr2021, she experienced trigeminal neuralgia attack, massive vertigo attack and eye was so swollen; on an unspecified date she experienced also sickness and couldn't eat anything down. The patient specified that right after she got the injection, they make you to sit there for 15 minutes to see. She lost consciousness, it was like they gave her a shot before you go on for surgery and the doctor had come over, they had to wake her up. She didn't know what happened, so that was the first thing and the doctor said that's out of all the 1000's of people they vaccinated she was the first one that passed out right after the injection. So, she thought may be that should be noted somewhere and she didn't get a headache that she has a condition called Trigeminal neuralgia which was extremely painful and it's like only 3% of the population get it and it's usually caused after major head injury, was the very next day her shot was on the Friday and then Saturday the pain was terrific and she had the trigeminal pain for a week, took a week to go away and then right after that the next week she had a massive vertigo attack. And she really didn't know all these things or side effects from her head injury. But her conditions are pretty rare, you only get them if you've got massive concussions and fractured skull and stuff like that which happened a long time ago. So she didn't know if the shot had anything to do with it. She has pulmonary problems so she was getting it no matter what because she can't go anywhere hery Pulmonologist won't let her leave the house unless she has to go to a doctor or an emergency room. And she did go to the emergency room because her pain medication wasn't working at all (Unspecified medication). She used to have migraine but after the head injury the migraine went away which she was very happy because she had severe migraine. What she didn't know was this Trigeminal neuralgia the nerve pain. The consumer further specified that she was so happy with the vaccine and she mean she doesn't care what the normal side effects are, she didn't have any other side effects her arm never hurts, she never had any fatigue or headache but she didn't know it was odd, the very morning she woke up Saturday she was in excruciating pain, its nerve pain that went down to the jaw, right under her eye and over the forehead and it's the most extremely painful thing that people get. She takes medication (Unspecified medication) daily to try to control it but sometime the pain is really really bad. She had been sick for the 3 weeks, she did not think anything had to do with the vaccine except the trigeminal. But it could have caused a massive vertigo attack which lasted 8 or 9 days. Today was the first day she was eating food in a week because she couldn't eat anything down. The patient was on a lot of steroids, she was reducing but she was still very plump so she thinks it's about 270 pounds right now. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.

About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation

dizzyness within minutes. was told by nurse onsite this was not an adverse reaction. the paperwork they gave stated otherwise. after about 30-40 mins the dizzyness subsided. no treatment. chest pain. not sure if heart or lungs. was not due to eating as symptom was steadily getting worse across 3 days whether I ate or not. was difficult to eat due to the pain. didnt matter if was sitting, standing or laying down. felt like saran wrap around my heart...sqeezing it...with pain. pain stayed centered in chest. behind sternum. still there, but tonight does seem a little better. was not intermittetent but was more pain sometimes and less pain sometimes. longterm outcomes unkn.

left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe

Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Tachycardia (HR in the 110s), substernal chest pressure, dizziness 15 min post vax Observation and fluids Sxs resolved after 30 mins of close monitoring NKA

patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out

First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.

01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.

Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambulance called, tested to rule out stroke and blood sugar issue but tested ok. Determined I had allergic reaction to vaccine.

Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.

About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.

Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.

As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. I fell forward and sustained bruising to my right cheek and temple. I will be reporting another report regarding the second dose with adverse reaction that is the same but required EMS and Emergency Room visit. Approximately 3 hours after injection I was getting ready for bed (as I work nights). I was talking with my daughter and I stood up and remember waking up on the floor. Bruising to the right cheek and temple. I did not seek medical attention and went to bed. I had no further episode but remained dizzy for several days.

trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; bad neck and shoulder pain; sore right arm similar to after a tetanus shot; This is a spontaneous report from a non-contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL1284, intramuscular on right arm from 05Jan2021 09:45 to 05Jan2021 09:45 as single dose (first dose) for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 05Jan2021 at 03:00pm, the patient experienced sore right arm similar to after a tetanus shot. On 06Jan2021, the pain in upper arm gone but by afternoon but the patient got bad neck and shoulder pain on right side that she treated with heat and Advil. On 07Jan201, neck pain still present and by late afternoon, the patient got a lot of pain in right elbow. On 08Jan2021, the patient still have the neck to shoulder pain in addition to the right elbow pain. It feels like she sprained her elbow and was having trouble lifting things like my tea kettle. The outcome of the event sore right arm/pain in upper arm was recovered on 06Jan2021; having trouble lifting things like my tea kettle was unknown; while the other events were not recovered. Treatment has been given for the event bad neck and shoulder pain. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.

Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.

I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.

Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.

Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, aching in joints., headache, chills with second shot.

Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination

felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."

Felt that my heart was racing , I also felt light headed. I was sent to the ER to be monitored for 4 hours.. they checked my vital and sent me home after everything was clear .

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic

On day 20 after the vaccination my knees starting getting sore- by 3 am I could barely stand on them- as the day progressed I had to use a walker & by late afternoon a wheelchair. The pain in my knees was a 10 out of 10.

At day 20 after the vaccination I got up in the middle of the night & could barely walk. My knees were very painful 10 out of 10. As the day progressed it got worse & I needed a walker & eventually a wheelchair.

not sure if it is covid; feeling unwell; headache; dizzy; sleep the whole day/ falling asleep; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as Pfizer Covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 04Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose of the Covid vaccine on 04Jan2021. She stated that the first day it was okay but on the second day, she slept the whole day and even when standing up cooking, she was falling asleep and on the third day, she was completely okay. After that day, she was okay until now. She was now feeling unwell, headache (she never gets a headache like this before, a really, really headache) and dizzy (all starting yesterday). She takes Tylenol and will be okay for 8 hours. She further reported that she did not have a fever. She added that on Sunday, she was dizzy and has an on and off headache but not all the time and also for today too. She is not sure if this is a side effect or if it is covid. She inquired if these are side effects or does she need a Covid testing. The outcome of the events was unknown. The following information on the batch/lot number has been requested.

Patient seated in observation area for a 30 minute observation after injection of Covid 19 vaccine. Patient after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was A&O x4, lungs clear to auscultation, patient stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on RA and B/p of 130/80. at 1016 covering provider ordered to give patient given 12.5mg of Benadryl liquid with 16oz of Water intake during observation period. Continued to monitor patient and noted that was able to ambulate at 1025 to bathroom with assistance but still experiencing dizziness. Patient monitored for a total of 45 minutes then discharged home.

No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.

Extreme soreness at injection site. Impacts ROM. Painful to lift left arm above head. Pain starts below the left AC and extends up to the acromion process. Intermittent relief when taking OTC pain medications.

unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.

A day after getting the vaccine, had fatigue, body ache, headache, fever of 101, sore throat, bitter taste, dizziness.

Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol for relief. still feeling weak. can't stand up long without feeling dizzy.

Pain in shoulder joint starting the morning after I received my first dose. Continued till date of my second dose and got worse after 2nd dose given in same arm due to medical recommendation for better vaccine response. Have pain on lifting arm. Can?t raise it more than 75 degrees without great pain. Trouble pulling or pushing with that arm or carrying heavy things. Have not had issues with this arm before vaccination.

Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck; Muscle pain; muscles in my neck are all tied up between my shoulder blades, my shoulders all was shrugging and I could never release the muscles back that is what I felt like.; Could never release the muscles back that is what I felt like/My muscles never acted this way; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Nurse reported that she had severe side effects but not an allergic reaction. She had the vaccine on Thursday (31Dec2020) and by Sunday (02Jan2021), she had a horrible headache, all the muscles in her shoulders and back were tightened up. And all the week long, she kept trying to keep care with hot packs and cold packs and Advil and Maxalt and all kind of things but could not. Yesterday morning (as reported), she lifted nothing heavy, did nothing different at all and she could not pick her head up. Patient had to seek for medical attention just at her doctor's office not at the hospital. She had to have somebody and take care of muscle pain. She still have the muscle pain she do have to go back but they did give a muscle relaxant. Patient reported that she never had a reaction ever like this. Nurse further stated that she didn't do anything as a precursor before the vaccine or after the vaccine. The muscles in her neck were all tied up between her shoulder blades, and her shoulders all was shrugging and could never release the muscles back that was what she felt like. Nurse stated that she just have to take the second shot, that was just the first one. Somebody told her that she have to report it because it took her off the work for two days. And her muscles were still tight and at all the way to my neck and still have headache. She had a shot on 31Dec2020, and symptoms started on the 2nd. Patient reported that she never had such kind of pain before and her muscles never acted this way. She was advised by her healthcare provider that there were side effects and this one she consider severe. She was advised to continue to take the second one. Outcome of the events headache/could not pick my head up and all the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck were not recovered; outcome of the rest of events was unknown. Information on the Lot/Batch number has been requested.

Received second dose of vaccine and had minor symptoms X approximately 1 day. On day 10 after 2nd dose of Pfizer vaccine developed vertigo requiring medical treatment and has not returned to work as of 1/29/21.

alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)

Patient reported tingling to tongue. No SOB nor difficulty breathing. Also reported feeling light headed. No antidote nor supportive treatment given. Symptoms resolved within 30 minutes.

FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES

61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after receiving first dose of Covid vaccine, began to feel lightheadedness 15 minutes later. Patient reports that she started off with a right-sided headache, and when she went to stand up took 2-3 steps forward and fell lightheaded, and and sat back in her chair. Denies loss of consciousness, chest pain, shortness of breath. Denies alleviating or exacerbating factors. Patient reports that they taken her blood pressure after symptoms, was found to be elevated, 200/100 systolic. Patient denies previous history of blood pressure medications. Denies previous reactions to vaccines

Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack and then gone completely after 10 minutes)

sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.

Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad headache started while driving home. Took Tylenol but 24 hours later still have headache. Arm hurts at injection site. Very tired. slept 14 hours and still tired. Temp has been around 99.5 when I've been awake enough to take it.

Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring. In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.

On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired

Transient global amnesia and fall the day after vaccination Elevated ESR 51 and CRP 3 Symptoms resolved spontaneously except for labs, still monitoring

Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm. Used Tylenol or Motrin PRN for relief as well as heating pad intermittently. After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists. Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder. Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.

Facial flushing and light headed immediately after vaccine. Provided Juice and granola bar at 17:50. Improved after a few minutes.

I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopped at day 3. After the second dose, 3 weeks later, the symptoms appeared later but held on to day 5 or 6, except the more extreme dizziness which I still have. It is worse on some days and there is some nausea in the mornings with headache. I have never had vertigo but this is what I imagine it to be.

AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPORTS FEELING SMALL AMOUNT OF DRAINAGE IN THROAT. ADMINISTERED 50MG OF DYPHENHYDRAMINE, IM, RO AT 3:43PM. PATIENT MONITERED VITALS EVERY 5 MINUTES. AFTER MEDICATION PATIENT REPORTS FEELING DIZZY AND "LOOPY" AT 5:17PM PATIENT COMPLAINS OF TONGUE SWELLING AND BLOOD PRESSURE ELEVATED. EMS CALLED, ARRIVED AT 5:34PM, PT TRANSPORTED TO NORTHSIDE HOSPITAL. FOLLOW UP CALL, NEXT DAY PATIENT STATES SHE WAS GIVEN STEROIDS IN THE ER AND PRESCRIBED AN EPI PEN FOR FUTURE USE.

Patient states feeling of light headedness. Vital signs were checked at 12:20pm. Blood pressure was 115/69, Heart rate of68, respiration 20 and sat 98%. Patient wanted to leave and was informed to go to ER if dizziness/lightheadness continues. Husband stated he understood as well.

6:00 am next day woke with a really bad backache hard to walk or bend or pick up something. Felt like that all day...very hard and stiff near back middle rib area both sides. Felt better if rested but if got up bad again. Very uncomfortable continued until the following morning. Got up today am 2/14 feel a lot better but slightly still there. Also had lymph node swelled a little in same arm as shot under collarbone. Hopefully my back isn't as bad as yesterday. Had to lay in bed a lot 2/13.

I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.

This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45. At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80. At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.

Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose. Tight Chest going on but I think it might of been anxiety. Phone consult with doctor and prescribe some steroids.

Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME labored breathing. Symptoms were more severe than the actual covid virus I had.

Patient presented for COVID vaccination today, first dose. Prior to receiving dose, she mentioned to RN that she has a history of vasovagal syncope following her shingles vaccine. She routinely has flu vaccines without any adverse reaction. RN requested I standby and observe while patient receives vaccine. Within minutes of receiving vaccine, patient endorses prodromal symptoms lightheadedness, hot flashes, then lost consciousness while seated in the chair. After approximately 1 minute, the patient did regain consciousness. She was given orange juice and crackers and felt well enough to ambulate to a chair in the observation area. Vital signs were WNL and she was monitored closely in the observing area. She continued to complain of "queasiness" often stating that she just feels that she would like to go lay down and nap in her car. Rechecked her blood pressure which dropped to 94/64, patient states she usually runs low but systolic within the low 100's. She was taken to a private hallway where she laid down on a stretcher. Blood sugar checked reading 121. She was given more water but she was uninterested in any more food, as she questions if the orange juice and the crackers were the cause of the queasiness. Blood pressure was rechecked and she was again WNL. Given her persistent fatigue and "queasiness", team lead contacted ED charge nurse to discuss case. The recommendation was to have the patient further evaluated. Discussed with team lead, and it was agreed upon that this was best course of action given her persistent symptoms. EMS was called. Per EMS report, patient's blood pressure did rise which patient attributed to excitement/anxiety surrounding the situation. Patient ultimately declined EMS transfer to ED. Her husband arrived to drive her home. Discussed the importance of monitoring symptoms for the next 48 hours. If she has any worsening "queasiness", weakness, fatigue, nausea/vominting, throat swelling, wheezing, dyspnea then she is to call 911 immediately. Patient verbalizes understanding and is agreeable to emergency services should any of these problems occur.

Sharp arm pain down arm of shot. Within 20 minutes of shot experienced moderately severe vertigo and dizziness, along with difficulty breathing normally.

patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.

I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an hour and I got up I couldn't remember names of anyone, went to hospital to rule out stroke. EEG and double echo both normal. MRA and MRI, no evidence of stroke, transient global amnesia, it took a couple hours for me to get back to normal. I also had a shingles outbreak 10 days post both vaccines.

Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed coughing spells, non productive after 2-3 minutes after the vaccine administration, she states she felt like fainting. Lung sound checked - no wheezing. Pulse Oximetry checked 96%. Observed for 30 mins in the field. Intermittent coughing still noted. Pulse oximetry remained 96%, no shortness of breath or difficulty breathing. After 3 0 mins, patient continue to cough , states she feels tickles in her throat that makes her cough and she has a headache. Patient given Benadryl 25 mg p.o. and monitored for 30 mins. Patient felt better after 25 mins of observation and minimal coughing , pulse oximetry @ 96-98% denies SOB or difficulty breathing . Patient sent home with husband and advised to rest at home and call 911 if she develops SOB or difficulty breathing. Followed up call over the phone at 5: 00 PM , patient states she fell asleep when she went home and no cough , no SOB or difficulty breathing.

Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.

Pfizer COVID-19 Vaccine EUA Patient became dizzy after receiving COVID-19 vaccination. RN took blood pressure and it was with in normal limits. Staff took employee to for examination. Employee was examined and released by provider. She stated that she was in a hurry to get to clinic and wanted to make sure that she did not miss her appointment. She is a diabetic and she has not eaten since noon and usually eats supper somewhere between 6 and 8:00 p.m (received vaccine at 5:50 PM). Pt also states she takes her evening dose of her blood pressure medication 6 PM and had not taken it prior to her vaccination. Pt also started oxybutynin 2 days ago. 1/29/21: Pt received Dose 2 of the vaccine with no issue.

chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.

Palpitations lightheaded nauseous Developed high blood pressure Elevated heart rate Blood Tests Dextrose

Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.

Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and nausea stopped by the next morning. But the ringing in my head/ears is still going on. It?s driving me crazy. It?s a high pitch buzzing sound that never stops. At times I feel dizzy and nauseous because of it.

Client states that she has weakness, body aches, and dizziness since vaccine. Continues to have these symptoms

Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.

The next day, when I woke up I was unable to stand on my left leg. Pain in the posterior knee. Felt like I was walking through mud. Joints were all loose. Just a really bad left knee pain. They a lower extremity doppler to that leg - to look for blood clot and that was negative. Physical therapy - taped my knee; pain was so bad I had to stay home a couple of times. My hands (both) were so painful. Like I had frostbite. Occupational therapy did hand massage and paraffin for the pain. And isotoner glove at night and that helps with the buzzing. I am 2 months out today from the vaccine and I'm starting to feel like normal. Took two months to fade away. It may have been because I was still having COVID antibodies. COVID antibodies on August started at 6.95. I'm not totally recovered right now but I'm close to normal. Doctor visit - January 29, 2021 and February 5, 2021.and February 19th. They put me on high dose of Steroids - 20 mgs Prednisone daily and another round of blood thinner -ELIQUIS mg which helped me with pain and joints.

First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the course of several weeks to both legs weakness, and then the right arm, tension in the jaw and the face (altered facial sensation). Poor balance. Symptoms continue getting worse. Unable to work.

Increased heart rate following second dose; they took her blood pressure which was 193; she feels a little lightheaded still; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm shoulder (as reported) on 29Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for 2 holes in the heart), complete heart valve replacement in Oct2017 and ongoing, "pacemaker" from Oct2017 and ongoing. Concomitant medication included metoprolol for thyroid condition, amlodipine for high blood pressure, clarithromycin (CLARITIN [CLARITHROMYCIN]) for allergies; all from 2017 and ongoing. Patient previously took first dose of BNT16B2 on an unspecified date for COVID-19 immunization and experienced heart rate increased. She was brought to the emergency room and they gave her an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. Family medical history included mother and sister died from lung cancer; father died of pancreatic cancer. Heart rate increased following second dose of Pfizer-BioNTech COVID-19 vaccine administered on 29Jan2021; onset of event was in the afternoon on 30Jan2021 while at work. Her heart kind of jumped, skipped a beat and then just took off; she could feel her body twerking. Her heart rate went up to 193 beats per minute. She went to the nurses station at work, they took her blood pressure which was 193-verified this as same number of bpm of heart rate-documented as provided. That nurse told her she should go to the hospital, so patient just left work and walked to the hospital which was a block away from work. She did not feel lightheaded, sick, or pain, just heart racing. She was again seen in the emergency room in response to this event, but was not admitted to the hospital. She was again given an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. The only thing still ongoing related to this event was that she feels a little lightheaded still. Relevant Tests: All were good. They tested her kidneys, heart did an X-ray, EKG; tested her liver and thyroid and they said everything came back good; They said her heart rhythm was fast, and irregular, but something else was normal-she does not remember what that was. She had no further details or results for testing/investigations to provide at this time. Outcome of increased heart rate was recovered while outcome of the remaining events was unknown. Information on the batch number has been requested.

Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort. Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.

I had 2 minutes left from waiting my 15 min after receiving my first vaccine and all the sudden I got very flushed/hot. And then light headed. It lasted about 5 minutes and I ended up staying an extra 30 more minutes. Then I was fine. No other problems.

With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., varicose vein in left thigh was extremely throbbing, I could barely walk on stiff knee. I had a trouble night of pain on Sunday 2-28, Monday , I could barely walk on left leg & still had thigh pain, I almost fell down stairs 2x from leg buckling, I did fall down in the kitchen and the fam. room from knee buckling, not supporting my body. I used heat, ice, rest, ibupfen, advil, tynelol, ben-gay, icyhot, CBD cream. I used it all. Today is one week and the thigh pain is gone but knee is still stiff. It no longer buckles, but I still can not fully walk. I am using a cane. I have been working from home all week, but can not cook for myself. I have to sit in a chair in the shower. I did contact my Dr., who said keep doing everything I am doing, that as long as it getting better every day. I am afraid to take 2nd dose.

On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.

I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.

Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after 30 minutes so I was allowed to leave the vaccination facility shortness of Breath started 35 o 40 minutes after injection. When I was was walking out to my car My daughter was in area and picked me up and she had Benadryl Took 2 Benadryl Shortness of breath started to improve after An hour of Benadryl. Hoarse voice improved some but continued to improve after second dose of Benadryl. Now on March 11 I still have a slight hoarse voice but so much better. I?ve been taking Benadryl every 4 to 6 hours regularly per my Dr I don?t have shortness of breath anymore but my chest does feel a little tight

After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.

Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.

Pt. c/o "feeling high" like she had some drink. She felt light headed. Denies SOB denies chest pain. @ 1040 BP 160/100, HR 84, RR 18. @ 11:49 BP 160/82. @ 1050 BP 160/90, HR 80, RR 18, no dizziness, Ox.Sat 97%, 160/82. Stated she is fine and wants to go home.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

Patient became sweaty, unresponsive, and felt dizzy. Patient was given orange juice and had her place her head between her legs to increase blood flow. EMS was called.

Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.

Patient was sitting in monitoring area status post covid vaccine injection (Pfizer 0.3mL). Patient complained of flushing, erythema noted on anterior neck and chest, and hive was observed. Patient denied shortness of breath. BP 132/92, HR 90, Pulse ox 98% room air. Benadryl (Lot #080012, exp. 08/2022) was administered 50 mg/IM per order into left deltoid @ 1337. EMS was called per protocol. 1340- Vital signs were 156/110, HR 84, pulse ox 98%. 1342- EMS arrived- VS 162/110, HR 85, pulse ox 98%. Patient then complained of feeling lightheaded. Patient was transported to ED without further incident

3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TODAY AND 2 BITES OF CANDIES'. GIVEN JUICE AND CRACKERS. 7:25PM 'FEELS BETTER'. AMBULATORY TO EXIT WITHOUT DISTRESS. 3-11-21 9:30AM PT STATES 'FEELS 100% BETTER NOW'.

A 61 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/16/2021. The patient experienced the following reaction(s) during the immediate of observation: 11:42am Patient c/o "dizziness and mumbling noise." Patient alert, oriented, and verbal. Patient assessed in treatment area. Patient was treated/managed as follows: 11:44am VS BP 118/64, HR 67, RR 18, O2 sat 98% on room air. Patient denies shortness of breath or difficulty breathing. No swelling noted to face, mouth, or tongue. 11:59am VS BP 134/80, HR 70, RR 18, 97% on room air. Patient reports feeling better and symptoms have subsided. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:08pm Escorted to car by sister and RN.

nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.

Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.

3-9-21 12:20PM 'DIZZY - ONLY ATE A BANANA TODAY'. A/O, W/D, RESP WITH EASE, NO PAIN, NO DECREASED LOC. FAMILY AT SIDE. 12:51 'FEELS BETTER' AMBULATORYTO EXIT WITH FAMILY, GAIT STEADY. NO ACUTE DISTRESS NOTED. 3-17-21 8:49AM 'STILL FEELS LAITTLE DIZZY'. ADVISED TO CALL PCP FOR FOLLOW UP.

Extreme dizziness, nausea, mild pain all over body. Tome Meclizine, 25, 2 pil,, 3 p.m. Advil 7p.m. 200 mg Some relief by 12p.m.march 19, 2021 Still dizziness, mild pain, cloudy thinking, not able to function

Patient called Health Department on 3/16/21 at 10:37 am and reported that approximately 40 minutes before call she became extremely dizzy. She has no history of dizziness and no history of health problems. Reports she does take Fosamax on Saturday and normally feels some nausea with that. She did take the Fosamax on 3/13/21. She questioned if this was a normal reaction and said it was severe enough that she did not feel she could walk to the office on the college campus. I recommended she call her doctor and if she continued to feel severe dizziness go to Emergency Room. I called her back at 4:54 pm on 3/16/21 and she reported she did go to the Emergency Room and they did a CT Scan and also some other tests but she could not remember everything. She said her blood pressure was elevated while in the Emergency Room. Was discharged and has a follow up appointment with her normal provider. Client called on 3/18/21 at 4:46 pm and said the dizziness continued and she was started on a steroid and meclizine by her provider.

At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.

I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).

I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow (injection was in left arm), and nausea. Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night. Symptoms continued until morning of March 20, 2021 and gradually lessened by evening. Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache. Ate a few saltine crackers to lessen nausea symptoms & drank ice water. Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.

1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.

COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CHILLS,

Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone

Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute observation section when she stated that she felt "swelling of her face and tingling of her lips." Blood pressure was 196/98, HR 85, O2 97%, Temp 98.1. Patient was alert and oriented x 4. Patient stated that she was very anxious today and has allergies to dairy and pollen. Patient confirmed that her husband was on the way to pick her up and drive her home. EMT administered 25 mg of Benadryl PO at 12:32 pm. Patient observed for an additional 50 minutes until her husband arrived to pick her up at 1:22 p.m. Patient stated that she was feeling better and was able to walk unassisted with her husband. informed patient to go to ER or call 911 if symptoms worsen.

Patient received vaccine then sat in the observation area. I was called over when she looked pale and felt dizzy a few minutes after receiving the vaccine. We took her vitals and her O2 was 98%, HR 61, and BP 92/67. Her normal BP is in the 110s. No history of syncopal episodes or diabetes. Patient then became unresponsive to questions and stared off into the distance for about 10 seconds. She never lost consciousness. She proceeded to gurgle up vomit and I called 911. She became responsive again and able to converse normally, but still felt dizzy. We wheeled her to the front, and EMS arrived. She agreed to go to the hospital due to the concern for her unresponsive episode, inability to walk on her own, and living by herself.

1130: Patient c/o dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased. PMHx: Epstien Barr, Bradycardia, Tachycardia Stage II Renal Disease Patient A & O x4, skin pink, warm and dry, PERRLA ~3mm Speech clear and appropriate. EMS and Physician on duty at bedside assessing patient. VS:1127:156/106-b/p, 60-hr, SaO2 96% on RA, 1141 VS: 154/104, Repeat 146/98 58-HR, SaO2 98% on RA EKG, VS as above. Patient advised to be evaluated in ED. Patient refused ambulance transport. Symptoms subsided, minimal at the time of departure ~1210. Patient taken to care via wheelchair. Daughter to transport to ED by Patient's own vehicle.

12hrs after my 2nd Covid Vaccine I was sleeping got up out of my bed at 4am and the room was spinning. I layed back down and had a burning sensation in my chest and my hands and feet were clammy. Several hours later at 8am same exact reaction when getting out of bed. Over the course of 3 days I remained Lightheaded.

Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).

Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.

About 50 minutes after the vaccine was given, my tongue began to swell and I experienced tightness in my throat and chest and shortness of breath. (This was occurring while I was driving myself home from the vaccination site.) I administered my Epipen. And I then drove myself to the Emergency Room, which is near my home. At the ER, I was injected with cortisone, Benadryl, and Pepcid, and had my heart and blood pressure monitored for about 3 hours and then I was released, with a prescription for 50MG Prednisone (1q/day) and 10MG Pepcid (2q/day) x 5 days (for both scripts). I finished the prescriptions, but am still feeling some discomfort in my throat and some dizziness.

started with slight headache early in the morning. I attributed this to pollen and allergies. It last most of day. Then at 4:30 my head began to pound. I felt dizzy and extremely nauseous. This lasted about 4 hours and then I felt much better.

Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat before i got the shot they seem to think my sugar dropped as soon as i had something to eat and drink i was fine

BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.

Low BP 74/40, low heart rate- 40, sweating, dizzy, gave ice pack on back of neck and under arms, took vitals after 10 min again HR 53- BP 82/43, RR 16 96% drank water, 14:55 not dizzy, sitting up, BP 133/82, no sweating, HR 50, RR 16, 99%, 15:00 took to car gave water for way home

Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before. I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.

Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.

Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressively worse-was at dentist, sent home, could not walk unaided (dizzy). Threw up in car on way home. Spent evening with these sympyoms gradually decreasing in strength, very fatigued, took effort yo breathe. Also soreness of arm. Next day: very fatigued, sore arm, but test of symptoms passed (little nausea, but not bad)

Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.

Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.

weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain, nausea

PATIENT STATES FEELS LIGHTHEADED AND HEART FLUTTERING. VITALS ARE BP 185/90, HR 103, RESP 20 AND O2 SAT 0F100%. MONITOR STRIP DONE WITHA HR OF 112 AND REGULAR. PATIENT MONITORED ANOTHER 15 MINS WITH HR OF 90 AND REGULAR. PATIENT ISTRUCTED TO GOTO EMERGENCY CLINIC IF SYMPTOMS RETURN.

total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon

Rapid Response team called for C/o dizziness, lightheadedness, weakness and numbness in all 4 extremities. She was admitted to ED

Pt felt dizzy after vaccine. Denies any chest pain, SOB, nausea or vomiting. At this time patient feels better and does not want to go to hospital blood pressure 160/93, 98,16 150/88,84,18

2nd day: Soreness of injection site 3rd day: Soreness of injection site with swelling at site 4th day: Soreness with sensitivity to touch throughout the upper part of the arm 5th day: Severe pain throughout the arm. Numbness in my fingers. light headiness, passed out for a few second. light tremors.

A short time after having received the vaccine, patient complained of lightheadedness, palpitations and was noted to have sustained high BP readings. Transported to ER via personal vehicle, refused transport. On follow up, patient reports having been started on new med for BP but otherwise recovered.

Following day: major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme tiredness (stayed home from work) 2nd day: big headache; very light headed; some coughing; short of breath; nausea (stayed home from work). Not restful sleep. 3rd day: pressure headache; very light headed (went to work). Very tired at night. Hard time sleeping. 4th day: light headed; pressure in head; short of breath when going for a walk; hard time sleeping. Since 4th day, haven't slept well; light headed; on-and-off headache; at work but moving slow. Feels like when I returned from being out with Covid + double pneumonia 6/30/2020-7/23/2020.

Dizzy about an hour later. Worked through it. Itching/swelling as in first dose in arm but handled with anti-itch sprays and cremes. In afternoon, nauseated and dry heaves. After 9:00PM, high fever, aches, constant chills throughout the night. Extreme thirst. Fever through the next day and used a COVID sick day. Symptoms gone by morning of 03/27/2021.

Fever, headache, aching neck, arms and hands. Fingers felt stiff and swollen, hard to move, but still looked normal size. Developed an egg size lump under left armpit that was very painful.

(03/04/2021) date of first COVID Vaccine, 17 days after the first COVID Vaccine I am experiencing vertigo, fatigue, abdominal discomfort, (all day) if I am active and have food in my stomach I will vomit. Received the second COVID Vaccine (03/05/2021) after returning home from the vaccine I vomited multiple times that day. Symptoms have not improved. Went to the doctor on 03/29/2021 for an evaluation. She recommended a COVID test. The test was negative. The Dr said my condition is an adverse reaction to the COVID Vaccine

Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.

I had my Pfizer vaccine on March 16, 2021. On March 17th I had a headache, body aches and fatigue which I expected since I had Covid in November 2020. Most of these symptoms only lasted 3 days. After the 3 days I had a continuing headache and started having jaw pain. On March 22nd I started having dizziness and a severe headache with jaw pain, fatigue and nausea. On March 23rd I got up abruptly and felt extremely dizzy and almost passed out. I am having continued sporadic headaches, nausea, dizziness behind my eyes with fatigue and a metal taste in my mouth especially when my mouth is dry. As of March 30th, only side effects lingering are dizziness behind my eyes and nausea

3/25/21 sore arm, tired achiness, headache, lite headedness-throughout day & night. 3/26/2021 same as previous day. 3/27/2021 at 6:30 am awaken unable to breath.- Both ears felt closed, throat felt closed. Immediately took a Benadryl, put Vicks on neck-throat area, used steamer for moist air through nose. Lasted close to one hour. 3/27/21 most of afternoon & evening extreme tiredness. 3/28/21 morning ok, by afternoon extreme achy tiredness again. 3/29 to present headaches.

Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available

Participant c/o dizziness and feeling "tingly all over". States has had numerous allergic reactions in the past. B/P 180/98, pulse 81, O2 sat 96% EMS arrived and assessed participant; B/P 188/ 118. Continued to complain of ongoing symptoms, agreed to go to E.D. to be further assessed.

felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.

Participant c/o of HA, dizziness and left side jaw numbness prior to exiting covid monitoring area; est. about 20 minutes post Pfizer Covid vaccine 1st injection. 1313 Escorted to covid monitoring cot and placed in semi - reclined position. 1317 BP 148 /88, P 79, R 18, 62; denies medical hx and allergy to any meds / foods. 1319 O2 sat 98% and participant voiced decrease in HA with no jaw numbness or feeling of heart pounding; denies numbness to upper extrems. 1324 BP 151/92, P 82, R 18, O2 sat 97% with participant voicing "it's all related to anxiety due to lots too for the day". 1332 Call 911 to site for response. Participant aware of call at time. 1337 Bp 176/102, P 82 and sitting on sit of cot. 1332 EMS on scene and assessment begun. 1345 Participant declined EMS support / transport to hospital. 1348 Ambulated to restroom with assist with no c/o; voiced "feels much better at time". 1350 Provided education on s/s to call 911 for immediate f/u and encouraged to notify PCP of event post vaccination. Participant voiced understanding and shared is scheduled to see PCP on 03/24. Discharged from site into self care with ambulation to car.

Woke up very dizzy, light headed, felt like diarrhea, hot, sweaty, passed out approximately 4 times, had a harder time breathing, than normal being on oxygen. Stayed in bed for approximately 27 hours, just couldnt function well. Didnt contact Dr. About it, had family stay with me for couple days. I know it was from the vaccine.

received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting. EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE. I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.

11 hours after?intense shivering shuddering 22 hours after, awoke to?shivering, sweating, dizziness, lightheadedness, inability to get out of bed, dry heaves 23 hours after?attempted to get out of bed, fell/collapsed/fainted sustained many bruises

pt states her arm felt like it was on fire as the vaccine was being administered. She became very dizzy and had a headache. On 3/16/21 her arm was sore at the injection site. Her throat hurt and when she swallowed she would have a sharp pain right between her eyes. Her left arm became very painful and every time she tried to move it would cause pain in her chest. She had diarrhea, sweating and had 101 fever. On 3/17/21 she had to have someone help her our of bed on this day. She felt like she was going to pass out. She had this feeling on at least 3 occasions. Pt had pain when opening her eyes, trouble breathing and having heart palpitations. She called her cardiologist with her symptoms and was told it was related to taking the vax. She had a televisit w/ PCP and she was sent to have a Covid test which was negative. She was told to drink plenty of fluids and rest. By 3/20/221 pt started feeling better at this time.

Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.

Woozy, felt like body was swelling, then numb, then tingling, then like a rag doll. Headache, nauseous. Red rash all over face. Very fatigued. Most of it lasted all day.. Next day, Friday, still very fatigued and a slight headache that comes and goes. Everything else was gone. Had no problems with breathing. No fever. Had no treatment.

Left arm started to hurt minutes after the injection, radiating down toward elbow and my arm started to go numb, especially the pinkie and ring finger. Difficult to hold my phone while waiting, I dropped it, then started to get dizzy. Called a volunteer over, who summoned another lady. They told me they were going to move me to another area, and attempted to help me there, but I fainted about 3 steps out. When they were lying me down on the floor, I came to and was oriented at that point. BP was somewhat low initially, but increased as I lay there, and oxygen levels increased from 94 to 99 before I left facility.

Patient had received covid vaccination and had ambulated over to monitoring area. Complained of dizziness and severe headache. States no history of migraines/headaches or dizziness. Assisted patient to sit down. b/p 161/111 hr 90 sat 98%. 1650 EMS called. 1651 140/76 HR 68 Sat 98% Neuro intact. alert and oriented. States does not take any home medications, no HX HTN. NKDA. 1657 EMS on site. Patient adamant that will not go to hospital. ems waiver form signed. 1657 BP 151/79 HR 70, Sat 98%. Patient denies further dizziness or headache. 15 minute monitoring time was to end at 1651. Patient stated felt better and wanted to go home and left facility.

Pfizer Covid 19 EUA The 61 YOF felt dizzy in Observation and was seeing spots. Upon further talking to her and her husband she has a history of anxiety. All vitals were within normal limits. She rufused treastment and transport. ED was contacted and an AMA was completed. Her husband was with her and assured us if she had any more issues he would take her to the ER. 2021-000202257

Relapse of Multiple Sclerosis symptom; Extreme vertigo; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6204, Expiration Date: unknown), via an unspecified route of administration on right arm on 15Mar2021 10:00 AM at single dose for Covid-19 immunization.The patient historic vaccine included first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL9267, Expiration Date: unknown), via an unspecified route of administration, on right arm on 22Feb2021 9:00 AM at single dose for Covid-19 immunization. Patient medical history included Multiple Sclerosis. No Allergies to medications, food, or other products was reported. Concomitant medications included other medications were received in two weeks. On 16Mar2021 at 03:00 AM patient experienced Extreme vertigo and aches in her bones concentrated in her hips and lower back. It also triggered a relapse of Multiple Sclerosis symptom as and she had significant difficulty walking. The pain has continued for days. She had been taking high doses of Aleve for days for the pain. Facility type vaccine: Pharmacy or Drug Store. he patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to vaccination, the patient was not diagnosed with COVID-19. The outcome of event was not recovered. .

ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).

feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.

LIGHTHEADED/ ACUTE HEADACHE INITIAL BP 143/98mmHg - [30 MINUTES POST] BP 139/88mmHg Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water.

Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.

At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.

dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.

having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.

felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.

severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.

heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.

Every time she bends over, if her head gets below her shoulders to pick something up she will black out; fever; everything in her body ached; vertigo; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 26Mar2021 10:00 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as single dose at age of 61-year-old for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medications included methotrexate; hydroxychloroquine. Adverse event following prior vaccinations violently ill from flu shot, ended up in urgent care, 20 years. The patient experienced every time she bends over, if her head gets below her shoulders to pick something up she will black out, fever, everything in her body ached, vertigo on an unspecified date in 2021. Clinical course: The first Covid 19 vaccine she ran a fever and everything in her body ached. Every time she bends over, if her head gets below her shoulders to pick something up she will black out. She reports she has blacked out in the shower and blacked out from leaning off the sofa to pet her dog. She almost went into her coffee table trying to pet her dog. This lasted for about 5 days after she received her first Covid 19 vaccine. After about 5 days it cleared up and went away. She called the facility that gave her the Covid 19 vaccine, a drive thru facility and they told her she had vertigo. She knows she didn't have vertigo because she didn't have these problems until after she received the Covid 19 vaccines. Outcome of event black out was recovered in 2021, and outcome of other events was unknown.

Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours

Lower back discomfort/mild joint pain Mild injection site pain Large swelling/redness at site for a week Mild/moderate loss of bladder control Vertigo/nausea Lethargy Chills/fever 102.9 Congestion/cough Headache Unwell for about 24 hours

Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her right leg; Weight Loss from 258 pounds, down to 208 pounds, back up to 214 pounds.; She has to learn how to walk again, she is in a wheelchair now; Having Problems Swallowing from the Stoke; Speech went down to 25% and now she is at 50%, because of the Stroke; high blood pressure; slept five days; Arm was Sore; Body was Sore; Diarrhea; Slept and was Totally Exhausted; This is a spontaneous report received from a contactable consumer (husband of the patient) and a contactable other healthcare professional. This consumer reported similar events with different doses of the same product; this case refers to dose 2; only this case is serious. A 61-year-old adult female received the second dose of BNT162B2 (solution for injection, Lot EL3246 expiry information not provided) as a single dose via an unspecified route on 30Jan2021 at 13:45 (at 61-years-old) for COVID-19 immunization. Relevant medical history included ongoing seizures (1964; began at 5 years old, minor seizures; under control in 1984, possibility configuration it is the right cocktail), and wound on her left leg (that was being treated by a wound doctor for the last 7 years). Concomitant medications included gabapentin; 300mg three times a day by mouth (6am, 2pm and bedtime) ongoing from 2014 for nerves; valproate semisodium (DIVALPROEX; 500mg two tablets in the morning and one tablet at 6pm ongoing from 2010 for seizures furosemide 20mg every 48 hours (odd days); States she takes it to reduce swelling (diuresis)on the leg wound leg; states he gives it to her on the odd day of the month from an unspecified date; metoprolol (50mg) one tablet twice a day (6am and 6pm), for Blood pressure management; ascorbic acid, zinc (VITAMIN C WITH ZINC; 500mg/50mg) once daily from an unspecified date for an unspecified indication; acetylsalicylic acid (ASPIRIN) 81mg once daily from an unspecified date for an unspecified indication; and pramipexole 0.5mg once daily at 6pm ongoing from an unspecified date for seizures. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; Lot EL1284) on 09Jan2021 (at 61-years-old) and experienced arm was sore, slept for two to three-days, body was sore, and diarrhea. The consumer reported that on 30Jan2021, the patient experienced her arm was sore, her whole body was sore for about five days, she had diarrhea for five days, and she for slept five days and was totally exhausted. The consumer then reported that on 22Feb2021, she developed a blood clot in her right leg. The reporter explained that her leg swelled up and turned dark blue, almost black. The consumer reported that the patient was immediately rushed to the hospital. Caller states they did all sorts of tests and confirmed she had a blood clot in her right leg. States she was hospitalized from 22Feb2021 through 26Feb2021, so for five days. Caller states the leg went back to normal color, the swelling went down and she felt good. Caller states they came home on 26Feb2021, and she was up moving around, and everything was wonderful. On an unspecified date in Feb2021, around the time of the first blood clot, the patient was diagnosed with high blood pressure. Caller states on 12Mar2021 she had a second blood clot that traveled to her brain which caused her to have a stroke. Caller states when they got to the hospital they said she had a stroke from a blood clot that was somewhere in her system and it traveled to her brain. Caller states she was hospitalized from 12Mar2021 through 16Mar2021 when she was released from the hospital. Caller states she was too sick to go home so she was transferred to Rehab Center. She was there from 16Mar2021-27Apr2021. Caller states on 27Apr2021, she was transferred for rehab. Caller states at the center they only give rehab once a day for 30 minutes and he only works five days a week. Now she gets three hours of physical therapy a day and it is seven days a week. States they are working to get her to walk again and she is receiving speech therapy. States she has to learn how to walk again. Caller states her lowest weight was 208lbs, and they weighed her in yesterday and she was at 214lbs. Caller states with the stroke when she was at the hospital, they put her on baby food because she was having problems swallowing. While at rehab center she went from baby food to mechanical food. On 27Apr2021 she went to regular food. Speech because of the stroke went down to 25% and now she is at 50% and she is also getting one hour of speech therapy at hospital. Caller states they recognized it is important to get as much therapy as possible in the first 90 days, they call it a boot camp and patients are limited to 90 days to repair the damage. After 90 days, that is it. States that is why it was important to transfer her to hospital to heal and get back to normal. Caller states she is in a wheelchair and they are trying to get her to stand up. Caller states at the hospital they were able to get her to take 2 steps. At Hospital they were able to get her to do special training and he was able to get her to take 4 steps. Caller states he has no idea where she is with the walking right now. States she did not do anything on the 27Apr2021, because that was arrival date. Therapy started yesterday on 28Apr2021 at Hospital. The consumer also reported that the patient's current weight is 214 pounds, from 258 when she took the shot and down to 208 pounds on an unspecified date in 2021. Treatment for the events included occupational, physical and speech therapies, as well as apixaban (ELIQUIS), rivaroxaban (XARELTO), and spironolactone 25mg once a day; takes in the evening at 6:00p.m. ongoing from 12Mar2021 for hypertension. The outcome of the events arm was sore, body was sore, diarrhea, and slept and was totally exhausted and slept five days was recovered on 04Feb2021. The outcome of the event blood clot in right leg was recovered on 26Feb2021. The outcome of the event second blood clot that traveled to her brain which caused her to have a stroke was recovered with sequelae on an unspecified date in 2021. The outcome of the event Having Problems Swallowing from the Stoke was recovered on 27Apr2021. The outcome of the events speech went down to 25%, back up to 50%, and weight loss from 258 pounds, down to 208 pounds, back up to 214 pounds was recovering. The outcome of the event high blood pressure was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021484454 PFIZER (Same reporter/patient/different doses/events)

Within minutes of receiving the injection I began to feel dizzy, a nursing provider took my bp approx 5-6 min after receiving the vaccination with a wrist cuff and it was 191/125 , she obtained a manual cuff and took it about 3- 5 min after the initial bp and it was 180/100. I felt more dizzy and laid down. I also had a rapid HR but did not take my pulse. The dizziness fluctuated and gradually cleared over 20-30 min. A third bp was 146/84 and a last bp approx 30min after the injection was 124/76 and I felt well enough to get up and walk.

Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.

Employee received Covid vqaccine, approx. 10 minutes later employee c/o dizziness b/p 178/90 Hr 64 02 sat 97%. Employuee states he is currently being treated by PCP for HTN. offered to call RRT and or transport to ED for evaluation. Employee refused. Recently started new b/p medication prior to leaving observation area employee reports dizziness resolved. b/p 161/93 HR 68 02 sat 97%. Employee to follow up with primary care physician

Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything else is okay

Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day They would come and go. Late afternoon, Biceps went into spasms all fingers aching. After nap at 06:00 woke up and all symptoms gone. On 01/10/2021, woke up with tingling and burning from bilateral knees to toes. Lasted 2 hours and then gone. In afternoon 1 episode of dizziness and hot flashes followed by chills. 01/11/2021 Slight headaches. No bodyaches or other symptoms.

some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation area, waited approximately 15 mins and then reported chest tightness, dizziness, rash and itching on her arms, fast heart rate, watery eyes, runny nose, and throat irritant. Vitals were obtained and pt was requested to wait another 15 mins for monitoring. During monitoring period, patient became to complain of increased throat irritation and new tongue swelling. Response team was contacted. During reassessment patient's symptoms decreased. Team decided patient was stable and did not require transport to the ED. Patient was monitored for another 15-20 minutes with symptoms resolving. Patient was advised to discuss reaction with her PCP prior to getting second dose of the vaccine.

Felt faint, sat down with loss of consciousness for seconds x 2 ,estimated . She felt her heart rate was fast. B/P 98/48 - 87/40 HR 92 weak , per pt.

Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately 21 hours after injection

became hot and dizzy and stated she had some facial pain. further assessment determined the response to be a vasovagal response.

20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.

Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy spell 7am (a few seconds); minute long dizzy spell around 3pm, another around 3:15, then a 2-hour long dizzy spell beginning around 3:30pm. Queasy till 9 pm, but no vomiting. Foot cramp again, so I got up and drank more water and took magnesium. Felt steadier.

0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. EMS ON SITE. VS: 168/71, p: 58; 97% O2 SAT R.A.; 0954: BP: 168/71, P: 58, 98% 02 SAT R.A. 1015: LEFT AND WENT TO HOSPITAL. ALERT, ORIENTED

left arm pain at injection site, barely able to lift arm above shoulder without pain for first 2 days. 2 weeks later, still painful at injection site and general left deltoid area. no pain to touch, just with movements. pain with certain range of motion

Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.

12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. PAIN ON INJECTION SITE. TOOK TYLENOL.

Headache, dizziness, swollen glands chin/throat sore throat and chills. Extreme fatigue. Covid test and ruled out.

2 hours after receiving the COVID vaccine, I experienced the following: light headedness, dizziness, severe headache, rapid heart rate, high blood pressure, tightness in chest and fatigue

Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal flu coming on, weak and dizzy. I felt that way for approximately 20 minutes and went lie down but began to feel more dizzy and then very nauseated. I then vomited several times and afterward began to feel steadily better. The whole even was approximately 2 hour before I felt back to normal.

Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.

Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVID dose #1 at staff COVID vaccination clinic - waited 15 minute observation then returned to workstation. About 20 minutes after vaccination began experiencing light headedness, anxiousness, agitation and heart racing. Symptoms increased over next 1-2 days then diminished over the following week. Did not report symptoms. Stated "feeling like myself now"

pt states she woke up next after vax she woke up with cold symptoms, ie; stuffy nose, coughing, body aches and headache. Pt states she has intermittent dizziness.

Felt woozy like; felt like she's drunk. Pt denies tightness in chest, jaw pain or heaviness in chest. Treatment: Rest and water also referred to primary care clinic as she refused to go to the emergency room for further care. The pt was able to walk without assistance and stated she was fine.

Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tiredness

The vaccine was injected too high in left arm. I know this because I am a retired pharmacist and when I removed the bandage noticed injection was near the shoulder and not in the mid deltoid area. The left arm/shoulder began to feel sore in the evening and was very sore the next day. Was unable to lift arm or move without pain. Over the next several days the severe pain decreased, but I continue to have pain in the arm, especially the bicep area. Range of motion is limited. Severe pain when trying to lift my arm from resting position while in bed. Severe pain when rotating arm inward. Pain occurs with certain movements.

(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.

Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.

19 hours post vaccination, sudden onset of dizziness and nausea, 1 episode of vomiting. Dizziness persisting.

chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.

Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21

Body Aches, headache, nausea, dizzy ness, feeling unwell, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA

I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt nauseated and hot. I closed my eyes for a few minutes and when I hope Ed the the intense dizziness subsided. I still feel a little dizzy, very tired and switch from feeling hot to very cold.

woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and hard to keep eyes open; feeling overall sick and getting very hot; threw up quickly three times water only nothing in my stomach. Got home and went to bed and slept for a few hours. Woke up and felt better. Headache and fatique so rested the day; next day felt better with headache and rested. Third-day slight headache but felt much better.

Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Nausea

Prior hx. of anapylaxis from ferrlicit, hives from gallalinium, sulfa drugs and clindamycin. Received Trastuzubam yesterday. Individual from pharmacy called and approved vaccine administration. At 11:37 am patient noted tingling in both arms and legs and slight light-headedness. Denied any trouble swallowing, facial or tongue swelling. states a little chest tightness but not enough to take her inhaler. Vital signs at 12:09pm BP 149/75, pulse 90, Pulse ox. 100%.At 12:20pm patient still admits to bilateral leg and arm tingling, no facial/tongue swelling or difficulty swallowing. No change in chest tightness.

Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 hours

patient reported generalized itching in her arms and legs as well as lightheadedness. She was given dephenhydramine 12.5mg/5l oral solution. Pt provided with water. Sx resolved. Pt was monitored for 30 minutes from symptom onset and 55 minutes from time of vaccine administration.

The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little. I was chilling so badly that I couldn't get to sleep! When I got out of bed in the morning, I could barely move due to severe muscle pain. I did very little all day, suffering from what felt like the flu: chills, loss of appetite, and "brain fog" such that I couldn't read or think clearly. My head felt warm, but I never took my temperature. The next morning, I noticed hives on my chest between my breasts and around the armpit of my left arm. The following morning, now about 45 hours after my second injection, I still had pink hives, and my left armpit was swollen so that it wasn't concave, as it always is, but convex. Touching my armpit hurt, and I think some gland in it was swollen. Similarly, a gland on the left side of my neck was swollen and painful to the touch. Today, now the fourth day since the injection, the hives have subsided, and my glands are almost back to normal. Overall, I am very glad to have had the opportunity to get the vaccine, but I haven't felt that sick in years.

chest pain , lightheaded and palpitations . felt flushed and dizzy about 1 min after vaccination. felt better after observatrion

Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertigo. Felt feverish but no temp. Severity so bad almost went to ER. Took Imitrex x2 with chest tightness occurring after 2nd dose. Lasted x3 days then pressure on right side of head eye for a month. Elected not to do 2nd shot due to above s/s.

Patient came to site for scheduled appointment to receive 2nd dose of Pfizer Covid. States she would like to reschedule because she was not feeling well. Reports she has not felt well since the first dose. States initially she felt dizzy and had a headache - the symptoms progressed to dizziness, headache unable to be relieved by medication, stomach pain and nausea. States she has consulted with PCP and lab tests will be ordered, she anticipates she will receive an order for a MRI of the brain. She also stated because of her symptoms she was considered by her work as a presumptive positive for Covid and was required to complete three Covid tests - all were negative. Encouraged patient to continue consulting with PCP and possibly an allergist. She will reschedule when she is feeling better.

Patient received second dose of Pfizer vaccine and after about 20 minutes of receiving dose began to feel dizzy and vomit. Heart rate slightly elevated. Patient was taken to emergency room for further evaluation.

Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ache similar to indigestion, loss of appetite, injection site pain, fatigue

Feeling a little dizzy, woozy, tired at various times of the day, Also started itching the first night in bed and had a rash, It;s gone now. I don't know if the dizziness if from the vaccine or Vertigo?

About hrs after receiving injection- bad headache started - same as with the first injection. Not debilitating. Then extreme fatigue started, some minor dizziness. Not debilitating. I work in a cardiology office. Administrator advised me not to come in. Ended up sleeping for most of the next 18 hrs. No nausea, no elevated temp. Just unbelievable fatigue.

Approximately 3 hrs. after shot, I had extreme tiredness and slept for approximately 6 hours. I had a headache before and after sleep. The day after shot, I was still tired, had a headache, chills and a 100 degree fever. By evening, I was feeling fine. No headache, chills, or fever. 2 days after shot, I had a headache only. 3 days after shot, in the evening, I was very tired, had a headache, felt nauseous and dizzy. This did not last long. I went to bed and slept fine. Woke up feeling fine.

01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.

Soreness at injection site and fatigue within several hours; headache next morning with slight dizziness

Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of vaccine at 1648. At 1700, pt reports slight dizziness 128/82, pulse ox 100, pulse 60. Denies respiratory distress, difficulty breathing. Urticaria absent. At 1715, 130/86, pulse ox 100, pulse 60 post oral fluids. Unchanged dizziness. Transferred to care. At care, pt presents with minimal lightheadedness/dizziness. Pt reports history of vertigo that has been triggered by fatigue. Pt thinks her reaction is due to a long day at work with difficult situations - she was very fatigued at the end of her shift, before she received her 2nd vaccine dose. Pt states she feels like she is about to get vertigo, but it never actually happens. Pt denies tongue swelling, lip swelling, or feeling like her throat is closing off. No rash, hives, itching. Pt discharged after about 30 minutes.

Patient reports feeling lightheaded after receiving her first dose of pfizer vaccine. Vital signs taken, BP 162/78, slightly elevated, no other concerns. Patient refused second set of vitals or any other care, refused any transport. Patient left by self.

Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within a few days it was painful to move my arm backward, upward and forward. The pain lasted over a week; I contact Primary Physician and he recommended ice and acetaminophen. I did that for several days and by day 10 it was spreading to my shoulder area and radiating down my arm. On 2/25 I went to urgent care (primary is 50 miles) and then my Primary is preparing consult for Ortho.

PT reported feeling dizziness, anxiety, and BP was 130/106 when reporting she did not he a hx of elevated blood pressure. Pt reported not eating anything all day except for two oranges. Pt reported feeling the room was "spinning". Pt given snack of granola bar, then rice crispies, and finished a juice box and a small water bottle. Pt was able to ambulate unassisted to bathroom at 1545. Pt called her husband to pick her up, and pt left with husband at 1555. Pt denied symptoms at that time.

Double vision Dizzy Elevated Blood Pressure Light sensitivity Fatigue Symptoms lasted for 10 hours, monitored BP, monitored other symptoms (short naps, kept eyes closed as much as possible, minimal light

Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.

WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.

Approx. 10 minutes after vaccine administration, patient reported feelings of lightheaded ness. Upon assessment, vitals were normal. Patient was advised to follow with up PCP

Within about 5 minutes after the injection, I experienced the following symptoms, in this order: 1) Light headedness 2) Increase heart rate 3) Hands tingling 4) Upper Lip numbness

Pt felt light headed, had Elevated BP 177/1106, HR 86, Pulse Ox 98% on room air, very anxious, placed on cot, feet up, with OS symptoms improved as did blood pressure

Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness

Pt. reported dizziness for less than 2 minutes while waiting in observation after vaccine. She ate right before coming. She was given a snack and water and waited another 15 minutes. After 30 minutes she felt better. Pt. instructed to go to the ED with any worsening or new concerning symptos. Pt. verbalized understanding.

About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and noticed numbness/tingling in my right little finger. I went to bed and woke up at around 2:30 AM, I had very hot, stabbing, shooting pain running up and down my arm into my neck and upper shoulder. I also had pain running down my arm. This pain was a 9/10 and lasted for 3-4 hours non stop. I was up most of the night and considered going to the ED. The following day, I still had numbness/tingling in my right little finger. I was able to move my arm a little more but not enough. The numbness/tingling took 3-4 days to go away and the arm soreness took 5-6 days to go away. I received the shot from a Pharmacy Intern. I do have shoulder problems but this was not normal. I am a RN. I am very thin, weighing around 107 lbs. I wondered about the technique used or the length of the needle, or the possibility that I was allergic to something in the vaccine. I was also very, very tired for 2-3 days. I do have a sore arm after the flu vaccine but not like this. I will not be receiving the second vaccine, even though I am immunocompromised. I did call my MD office but did not go in.

Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of being high lasting 10 minutes, elevated heart rate, dizziness and weakness for 1-2 minutes length, blurred vision and "brain fog" lasting for about 24 hours

The first reaction - 15 minutes after the vaccine - I felt really dizzy and loopy. She told me, I think you better sit back down. I felt better after sitting there for 30 minutes after. I didn't get dizzy again. I finished my workday. Next morning, I woke up with a fever 100.8 (about). I woke up with sore muscles - I tend to get sore muscles easily but I felt more sore than normal and I had a headache. Fever stopped after 24 hours. Note: I also get dizzy really easily - and so it isn't difficult for something to make me dizzy. I also felt really tired. And over the weekend, I felt nauseated (not initially but over the weekend.) And that lasted until about midday Monday (over the weekend) to be getting better . I took Tylenol and I rested. That helped with the symptoms.

Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT came to my aid and took vitals all looked OK. I stayed in place until I felt better about 30 minutes. For the rest of that day and the next day I was extremely tired, a little nauseous, and kind of out of it. The third day I had very sore left arm at site and very sore and tender lymph notes on left side of Arm and trunk. Six days after the shot I came suddenly down with a massive headache and diarrhea. Al has since resolved and I am on day eight.

2nd dose of the COVID-vaccine administered on the morning of 2/18/21. Within the hour after administration, severe pain on left shoulder (site of administration) was experienced. Swelling, consistent aching pain, and limited range of motion/inability to lift arm over her head. Motrin for 2 days was self administered with improvement in severity of pain but recurred when Motrin discontinued. Motrin was taken as needed thereafter and was the pain continued until 2/26. Employee was followed up on 3/10 and verbalized that the pain had fully resolved. No further interventions.

I lost muscle control while playing tennis for about 5 minutes. After that I felt very tired, queezy, dizzy for about two days.

Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became light- headed and fell. My legs and arms turned red and warm and started itching. Itching subsided in an hour but redness remained for several hours. After itching stopped chills started and lasted several hours . By 7am symptoms were gone except for redness.

Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose discharge, loose stools, headache, light nausea but did not vomit. Still not feeling well. Symptoms have decreased and can now sit in a chair as apposed to lying in bed.

Pt. voiced hx of difficulty breathing and rash after taking miralax.Pt states her PMD recommends she get CODID-19 vaccine, Our medical director consulted and agreed to give with 30 min wait time, near onsite paramedics. I vaccinated pt. next to paramedic. 10 minutes later pt. c/o dizziness, SOB, trouble breathing . Paramedics assumed care, Epi Pen administered. Ambulance called pt. soon felth better after O2 and Epi. No LOC. Pt. left in ambulance talking and thankful.

Received 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Patient Reporting feeling dizzy, HX of autonomic dyxreflexia. HX of vagal response with pain/anxiety stimuli. EMS response, fluids, BP 53/33 HR 46, O2 sats stable. Transported via EMS to ED. Received more normal saline fluids in ED.

The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain was so severe that I could not move my head or arm all night. I took Advil but could not sleep from the pain. When I did manage to sleep, I would have horrible dreams. By morning, I was feeling better but still sore from my neck and arm. I felt very tired and rested the entire next day. Pain has not returned. It was very scary.

MEMBER BECAME DIZZY AFTER LEAVING THE OBSERVATION AREA. SHE WAS LEANING AGAIN WALL NEAR TRIAGE 1 AREA AND EMT OBSERVED HER, RETRIEVED WHEELCHAIR FROM TRIAGE 1 AND BROUGH HER FOR EVALUATION BACK TO TRIAGE 1. ON SITE CLINICAL LEAD AND PHYSICIAN ON SITE NOTIFIED. VITAL SITES ASSESSED AND REMAINED STABLE: 149/77 WITH HEART RATE OF 76. CONTINUED TO MONITOR WITH SYMPTOM RESOLUTION FOR A TOTAL OF 30 MINUTES. SHE WAS WHEELED TO FAMILY MEMBER AT CONCLUSION OF RECOVERY BY EMT.

Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull. upper chest and back of neck with horrible headache, Fever of 101.4, chills but major sweating. Ear aches in both ears from headache. Stomach upset for 4 days and couldn't eat. Body aches. Sleeplessness. Very light headed couldn't think for 4 days.

The day after the vax (Friday) All day my arm hurt so badly I could hardly raise it up. Around 7:30pm, I got nauseous, a really bad headache and had really bad chills. I got two heating pads out, one for my arm and one to warm me up. It lasted ?til about 3am and then it was over. My arm is still a little tender, but otherwise I am back to "my normal".

Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour. I am four days into symptoms. I still have some chest heaviness and still having asthma issues which includes coughing. I also had side effects of sore arm, chills, fatigue. Did not seek treatment. I had no idea how long this would last. I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER. I have suffered with this since Saturday.

Started seeing her eye become bug eyes and hurting started to slur speech and not about to walk. Called her neuro doctor on 3-1-21 he said to take her to the eye doctor so I did. They told me her eyes are dry to put eye drops in. Called her neuro next day he told me to take her to the ER. They diagnosed her with Graves Disease and now she is showing symptoms of Graves Disease. She has never had any problem with her Thyroid. Had blood work done back on Jan 20th 2021

Guest completed post observation period and was check out when they became lightheaded and requested a chair to sit in. Guest reports lightheadedness is common for them as they are a cancer patient. Guest declined aid response and was moved in wheelchair to their personal vehicle to go home with their husband. No interventions beyond providing wheelchair. Guest reported improvement when sitting.

March 13 was vaccinated at 2 PM and 12 hours later she began to feel twitching/shaking in all extremities associated with difficulty walking due to the "jerking twitching"..

Dizziness, feeling disconnected, off. Happened immediately. Felt better the next day but have had the same feeling since the 3rd day. This is day seven.

No symptoms after the vaccination on the day of or the day after getting the vaccine. Two days after the vaccine, while at orthopedist (for a Rotator Cuff Surgery), I began to feel dizzy. I sat down for a few minutes, drank some water, and then resumed my therapy. After the first set of my 4th exercises I began to get dizzy, I sat down on the PT table, then laid down and fainted for about 1-2 seconds. My blood pressure plummeted to 60/?. EMT?s and an ambulance were called. I was given an IV and taken to hospital. In the ER, my blood pressure elevated to 205/121. (I think that was it.) I was given a cat scan, ekg, chest X-ray, blood tests, etc. All tests were normal except a very slight (by one number) magnesium level. I was admitted for observation and more tests where performed. My blood pressure remained high, but I had no more dizziness or syncope. I was given many more blood tests, imagining, ultrasound of heart, ultrasound of carotid arteries, ultrasound ?bubble test,? nuclear heart treadmill stress test. All tests were normal. The only change in my health that can be attributed to this episode is the Covid vaccine.

?Pulled? hamstring muscle for no reason. Unable to stand or bend leg for days On day 3 and finally improving. Did nothing different to strain the muscle other than get a vaccination. The only thing I did differently that day.

a little bit of hip and back pain; a little bit of hip and back pain; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk/Noticed increase in her pain; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203, expiration date: Jun2021), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization and for autoimmune deficient. Medical history included sjogren's syndrome, rheumatoid arthritis from 2016 (reported as about 5 years ago), hip replacement, autoimmune deficient from 2007, and hip dislocates three times a year. Concomitant medication included tofacitinib ongoing citrate (XELJANZ XR, lot number: DR2042, expiration date: 31Jan2023), hydroxychloroquine, pregabalin (LYRICA), all three for unspecified indication. On 04Mar2021, the patient noticed increase in her pain. Such pain that she couldn't stand up or walk. The patient also had a little bit of hip and back pain on an unspecified date. The patient clarified that she has oxycodone as pain medication (med). The patient stated that she has too many medications that she has to take. Stated that her brain was dying. The patient also stated that she was doing fine and hasn't had pain like this. The patient did not know if it was an adverse reaction or what. The reporter seriousness for such pain she couldn't stand up or walk was assessed as disabling. The outcome of the events was unknown.; Sender's Comments: The causal association cannot be excluded between the reported events and vaccine use based on strong temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.

62 years old female called to report an adverse reaction after she received her first Pfizer dose on 03/18/2021 @1330. patient report that on 03/20/2021 @1030 she developed dizziness, lost balance, fever and shaking. patient denies any allergies. patient reported that she is taking Lyrica, Lamictal for facial nerve pain. and amitriptyline to help her sleep. patient was instructed to drink plenty of water and keeping hydrated to help with the dizziness, patient was instructed to take tylenol to help with the fever. patient was instructed to seek medical attention if the symptoms got worse.

Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swelling throat felt like olive stuck in it I called Kaiser. Talking to them chest began stinging hurting pressure. Told to call 911. I hung up walked two blocks to urgent care. Chest really hurting feeling dizzy face eyes swelling throat lump getting larger. My breathing rate normal , blood pressure normal , oxygen normal. They took me back gave me epinephrine and depo modral shot in right buttock cheek. After few minutes felt better chest stopped increasing in pain throat started feeling better, face still swollen. Told me good thing I walked instead of waiting for 911. Very scarey. Told to remain up for 24-48 hours give epi if needed again. Taking 180-360 mg 24 hr Allegra daily. I stayed up 36 hours drank water . Told can not take second shot. No vaccines until I get tested for what caused allergic reaction. Today March 23 face still off and on swelling and eyes. Seems when I begin to move around swelling starts again.

Date and time adverse event started: pt was vaccinated on 3/11/21, she felt fatigued from 3/12-3/17, on later developed nausea and dizziness on 3/19 until today. recommended to call pmd in am for possible evaluation. symptoms could be from other medical conditions.

Felt dizzy, had metallic taste in mouth. Numbness & tingling of lips, tip of tongue. Dizzyness got better after 15 minutes. Tingling of lips & tongue better after 1 hour, but still present. Face felt hot & flushed 40 minutes after shot. Also had some "burning" of veins in wrist . Metallic taste continues.. Some itching of face.

I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer vaccine #1--flushed/hot, strong metallic taste, chemical smell, tachycardia (156-158), nausea, some chest discomfort and dizziness. BP 158/85 (my normal is 100/60). O2 sats 98%. I did not feel anxious until heart rate would not come down to baseline. Clinic staff monitored me and did not treat. Allowed heart rate to decrease over time. Took over 20 minutes to get below 120. At 35 minutes, it was below 100. Stayed at clinic for one hour and released. Still had metallic taste (over 3 days now), loss taste, loss of appetite, headache, and fatigue.

Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger tips, hand cramping off and on for 2 days. Not able to eat. Had to start taking Zofran on 4th day to be able to start slowly getting soft food in system.

Initially light headed and sever headache. The next day, developed severe skin burning sensation all over body, including inside of mouth. This pain has increased as the days went on. This pain is severe, and continues into now 10 days. Dizziness and stomach upset has increased. Ringing in the ears and increased sensitivity to sound. Also experiencing weak and shakiness.

Felt the vaccine immediately in arm, Got a funny taste in my mouth, Started feeling dizzy before I stood up, Moved to a different chair from injection chair location. Passed out. Never vomited but become very nauseated. These symptoms all occurred within five minutes of the injection. Ran low grade fever all day on March 24 (day after).

2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, noticed the armpit lymph nodes swollen and slightly sore to the touch. Symptoms same on 03/23. On 03/24/21, noticed a red rash on outer part of upper arm to the elbow. Sweats and chills in PM and 2 fever blisters appearing on moth on left side. Morning of 03/25/21, rash worsens, sweats and chills continue. Toward afternoon, lightheadedness and trembling in hands. Felt better after lunch, some lightheadedness, still.

Within 15-minutes of vaccination, the patient reported dizziness. EMS evaluated the patient on-site. The patient was hypertensive (175/97) with a FSBG of 152 mg/dl. EKG demonstrated NSR, rate 86bpm, no ST elevation. EMS transported the patient toEmergency Department for further evaluation. In the ED, the patient reported dizziness, lightheadedness, near-syncope, aching headache, generalized fatigue, and weakness. Physician administered 25mg PO Meclizine. Upon reevaluation, the patient reported improvement and was discharged with diagnoses of Vaccine reaction and Dizziness.

Ever so slight tingle in tongue within 30 mins with difficulty moving legs. Arrived home and slept 5 hours. Spouse woke me up to eat. I was polite and took a few bites. Went to bed @ 10 pm. The next morning I woke in the fetal position and COULD NOT MOVE! Called husband for help. He lifted me to the sit up position by my rib cage. Very difficult to move for 4 days. Had Gammagard treatment on March 16. 2021. That was a mistake, I guess. I could not even think clearly enough to try to fill out this form.

Vertigo I Saw my doctor regarding vertigo and he prescribed Meclizine HCI 12.5 mg 2 times a day. He checked my ears and they were fine. I am going to Physical Therapy April 5 to be evaluated.

Started w/slight dizziness next day that increased during day. At 3 am awaken from sleep w/extreme vertigo/non- stopped vomiting for a few hours. Zofran from doctor stopped vomiting. Excessive sweating chills and hot flashes But no fever. Could not walk on own for 24 hours. Still experiencing dizziness if stand up or bend over too fast. Ringing in ears.

Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at injection site. I left work early and went home to lay down. I took 2 aspirin. I slept for 20 minutes and woke up feeling better. My doctors office was closed since this happened on a Friday. I consulted with a friend that is a RN and she advised going to emergency room. I have horrible health insurance so I didn?t want to pay 650.00 to go to emergency room. I?m not sure I want to get the second shot since I have heard that adverse reactions increase with the second shot.

Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pressure

Pfizer-BioNTech COVID-19 Vaccine EUA. Dizziness starting approx. 1 hour after shot; extreme fatigue and sleepiness occurred approx. 5 hours after shot. It is now 14-1/2 hours after the shot and I am still dizzy. I fell asleep for 3 hours. I'm still tired but not falling asleep at the wheel. Pain at injection site started approx. 7 hours after shot and still hurts.

Patient returned to the pod at 1219 after receiving her vaccine at 1201. pt states when she got to her car she began to feel dizzy and lightheaded. pt is also now having heart palpitations. no shortness of breath. no other symptoms. pt was assessed and vitals taken. bp is elevated at 189/120. all other vitals normal. additional rig was called for transport at 1243 due to rig on scene being dedicated to the standby. pt was further treated with an iv 20 gauge saline lock left forearm, and a 4 and 12 lead on the cardiac monitor. pts 12 lead showed a sinus rhythm with right bundle branch block. pt states she has no cardiac hx. kunkel medic 6 arrived at apprx 1255 and transported her to at 1300.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: carries APIS tablets which she uses if feels like have an anaphylactic episode. Waited an hour and left with no complications

difficulty breathing and slight light headiness. Took two puffs of inhaler. breathing a little better, light headiness still on going.

Skin flushed red on hands and arms, blotchy red spots on same.dizzy, felt like had a vise around head. Started sneezing and increased congestion. Within 15minutes of shot.

Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, itching, rash, numbness. Patient requested to only have 25mg of Benadryl administered. Per Dr. ok to administer that amount. Benadryl 25mg IM in the left deltoid at 11:30 AM by RN

Woke up with severe vertigo. Could not walk, threw up several times in the course of six hours. Slept most of the afternoon, but was very nauseous could not stand up all day. In the evening started feeling slightly better and could walk to the bathroom unassisted.

Mild to Moderate Stomach Cramping began approximately 3 hrs after vaccine and were off and on for about 36 hrs. Also had mild Lightheadedness during the 36 hours.

On 3/20/21 pt started having diarrhea. Then she started getting chills, body aches, headache, dizziness and nauseated. Her back and legs are hurting. She has had these symptoms for over a week. She has been taking anti-diarrhea meds and Tylenol and Advil. Pt will contact her PCP.

onset of reaction 16 mins after injection: pt reported dizziness, sweating, throat irritation. No difficulty swallowing, no difficulty breathing. VSS, pt A&Ox4. MD at bedside, pt c/o lip and tongue numbness. MD ordered IM Benadryl 50mg. medication administered. EMS called for further observation and treatment. Pt left facility A&Ox4 in stable condition via EMS to ER.

After taking the vaccine, that evening my breathing worsened and I also had a gout flare-up. The gout pain was so intense even after taking two pain pills, it kept me up all night. I was unable to report to work the next day and had difficulty walking for the next 3-4 days and breathing for the next week. I was even getting up 2-3 times on some nights gasping to breathe.

I have felt unwell since I woke up on Saturday morning. Saturday - low fever, dizzy, general malaise Sunday - low fever, general malaise, stayed in bed Monday - low fever, gastrointestinal distress, very very tired Tuesday - very very tired

Patient felt light-headed within a few minutes post vaccination. She was transferred by EMT to the hospital for observation.

initially felt light-headed and dizziness, then had flu like symptoms lasting 24 hours. The lymphedema left axillary area lasting about 24 hours after first dose. Had a mammogram in March 2021 and it showed a spot on the left breast.

very sick/Horrible; very painful muscles; very painful joints/The pain in all of her joints and muscles was a total nightmare; extreme weakness; very weak hand grip strength; Anorexia; unable to walk, stand up or sit down without max assist; unable to walk, stand up or sit down without max assist; Headache; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: BL9264) via an unspecified route of administration, administered in arm right on 10Feb2021 12:30 as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has no COVID prior to vaccination. Patient is not pregnant. No Known allergies. There were no concomitant medications. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261) via an unspecified route of administration, administered in arm left on 21Jan2021 11:00 AM for covid-19 immunisation at the age of 62 years old. Since 12Feb2021, patient was very sick, very painful muscles, joints, extreme weakness, very weak hand grip strength. Anorexia, unable to walk, stand up or sit down without max assist. Headache. Horrible. The pain in all of her joints and muscles was a total nightmare. Here it was nearly a month after, she was still quite painful and suffering with joint and muscle pain and weakness. These events resulted in physician office visit and emergency room visit and received treatment for the events, which included pain medication. Patient had COVID tested which included nasal swab (undated) and PCR on 16Feb2021 post vaccination, both results were unknown. Outcome of the events was not recovered.

I woke up at 5am the next morning feeling like my whole body was frozen. Every joint seemed stuck in place. It was bad everywhere, but worse on my left side -- shoulder, elbow, wrist, hands, and knee. Also my right hand. I took ibuprofen and went back to bed. I wasn't able to do anything. I was extremely tired. I took ibuprofen throughout the day to manage the pain and slept much of the day. I also was coughing quite a lot. Today I feel mostly back to normal. Very little pain or stiffness in my left shoulder, elbow and wrist. Less coughing too.

Fell on floor landed on butt Couldn't get up Was still sitting on floor and fell over on my face All within 2 min

After 15 minutes of waiting and as we were leaving I started with a headache and had problems breathing. By the time we reached the car, I felt worse and went back inside to the paramedics. At that time I was having heart palpitations, problems breathing, BP was 194/120, felt lightheaded and dizzy. Was having problems with walking. The next day I woke up and my hands were curled up, hips were sore, body aches, hard to walk shuffling instead of lifting feet.

I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pictures that were kind of ridiculous and seeing things; Severe headaches; Heard a lot of noises in head; body hurting severely where she couldn't walk; body hurting severely where she couldn't walk; no appetite; nauseas; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left, at the age of 62-year-old, on 18Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications were not reported. The patient previously received flu shot as immunization and did not get any reactions and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) on 28Feb2021, single dose for covid-19 immunisation and experienced very achy, some fever, some diarrhea, one episode and a big headache, difficulty Sleeping, and intense sensations. The patient experienced severe side effects/ bad reactions three weeks after receiving the second dose of vaccine. The patient experienced visual pictures that were kind of ridiculous and seeing things (medically significant) on 19Mar2021 with outcome of recovered on 21Mar2021, severe headaches (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, heard a lot of noises in head (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, body hurting severely where she couldn't walk (non-serious) on 18Mar2021 with outcome of recovered on 21Mar2021, fever (non-serious) on an unspecified date with outcome of recovered on 21Mar2021, diarrhea (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, in tears from intensity of the sensation second half of the day after receiving Pfizer Covid Vaccine (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, no appetite (non-serious) on 18Mar2021 with outcome of unknown, nauseas (non-serious) on 18Mar2021 with outcome of unknown, feeling out of body experience (non-serious) on an unspecified date with outcome of unknown. The diarrhea was reported as much more intense. The patient doesn't know how else to describe it, except it was very intense and severe. No appetite and nauseas which lasted 2-3 days, it's almost like feeling out of body experience. The events did not require a visit to Emergency room or Physician office. The patient did not receive vaccination within 4 weeks prior vaccination. No relevant tests performed.; Sender's Comments: Based on the close temporal relationship, the association between the event "seeing thingis" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Woke up on 3rd morning with excruciating hip pain, unable to bend; Woke up on 3rd morning with excruciating hip pain, unable to bend; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 2) via an unspecified route of administration, administered in left arm on 23Mar2021,15:00 (batch/lot number: unknown) at 62 years old as SINGLE DOSE for COVID-19 immunization. The vaccine was administered in Other vaccination facility. The patient's medical history included MGUS (Monoclonal gammopathy of undetermined significance), Ehlers Danlis syndrome 3, and iodine allergy; all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medications included clarithromycin (CLARI), estradiol (ESTROGEN), progesterone (PROGESTERONE), methylphenidate hydrochloride (RITALIN), and testosterone (TESTOSTERONE); therapy dates and indications for all were unspecified. The patient previously received the first dose of the BNT162B2 via an unspecified route of administration, administered in left arm on 02Mar2021 17:00 (batch/lot number: unknown) at 62 years old as single dose for COVID-19 immunization. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 26Mar2021 07:00, the patient woke up on 3rd morning with excruciating hip pain, unable to bend. It was unknown if patient received treatment as a result of the event. The patient has not recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Started on April 1 I was hurting in m y grove area, Friday April 2 I went to the clinic I had my shot at. They did a chest extra to make sure I didn?t, have a blood clot. When home on Saturday I could hardly walk and get up on my own. It would rotate to both hands and wrist couldn?t bend my fingers. Went to Dr took labs if need contact physian. Went to ER twice and gave me a steroid shot. Gave me pain medicine and medpack

Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continued. MRI and CT scans confirmed that the patient experienced a transient ischemic attack (TIA) and Veretebral artery dissection (HCC) between 4/10 and 4/11.

* On 4/2/21 - Fever 103.2, Fatigue, No appetite, Dizziness. * On 4/5/21 - Severe chest pain. Went to ER. Transferred to clinic in. Admitted to clinic on 4/5/21: - Test: Ultrasound, Xray, Lab Tests, Electrocardiogram - Outcome: Pericardial enhancement adjacent to the left ventricle with no effusion - Treatment: Motrin 400 mg/4 times a day, Protonix 40mg/day to protect stomach

INFLAMMATION ALL LEFT SIDE OF BODY,PAIN IN LEFT ARM,SPREAD TO SHOULDERS,NECK AND RIGHT ARM,TACHYCARDIA,THROAT TIGHTENING,DIZZINESS ON STANDING,HEADACHE,FEVER,NAUSEA,UNBEARABLE MUSCLE PAIN,WEAKNESS ALL OVER BODY STILL TODAY,PAIN BETWEEN AXILLA AND LEFT BREAST,DECREASED APPETITE,I GET TIRED QUICKLY,AND EVEN TODAY,,NAUSEA,DIZZINESS BODILY WEAKNESS,HEADACHE,AND I STILL HAVE INFLAMMATION....I THOUGHT I WOULD DIE!!!!,THE ADVERSE REACTION WAS EXTREMELY HORRIBLE

cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose; cold sores on lips after second dose; threw up after second dose; soreness after second dose; dizzy and weak after second dose; dizzy and weak after second dose; chills after second dose; sweating after second dose; dry heaving after second dose; nauseated after second dose; dehydrated after second dose; hasn't eaten for 5 days after second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FR8737and expiry date was not provided), via an unspecified route of administration, in left arm, on 07Apr2021, as a single dose (at the age of 62-years) for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN6201 and expiry date was unknown), via an unspecified route of administration, in left upper arm, on 05Mar2021, as a single dose for COVID-19 immunization. The patient arm hurt after first dose (began immediately and lasted for about 4 days) which was resolved on 09Mar2021. Patient second dose was scheduled on 27Mar2021, but she did not get it till 07Apr2021. It was reported that on 08Apr2021, patient had such an awful reaction to the second dose of the vaccine. She started to get dizzy and weak, chills, everything was a blur, sweating, could not drink threw up if she tried dry heave went back to sleep and slept for 48 hours had just chills the whole time. She was in bed sleeping trying to drink, getting up to go to the bathroom and feeling like she was going to die for the next three days. She was nauseated and is still nauseated and could not drive. She took Tylenol an antiemetic at urgent care that stopped. She took Zofran with the saline solution infusion and she went home and slept. She was dehydrated and had soreness all over. On 09Apr2021, she could not roll over and had a sore on her left butt cheek that was still there cold sores on lips. She thought the sore on her left butt cheek came from laying in bed so much, and it was not in any other space but that one spot almost like she would have gotten the shot there, but she didn't. On 10Apr2021, patient felt like she was going to die, and went to urgent care and asked if they could give her fluids. They gave her fluids and Zofran and that helped a lot. This one shocked the hell out her, she thinks it was her gums that started to bleed on 11Apr2021. She had the best oral hygiene and went to the dentist all the time. She was flosses like crazy. She started to drink a ton of water and has not seen it since. She cannot guess what the reason was. On 11Apr2021, she could function a little and had chills again last night and sweating. She did not have a fever. She ate chicken noodle soup water and a little bit of ginger ale. She started to feel better, but not 100% better not even 90%, not even 80%, but was heading towards the right direction. Patient also hasn't eaten for 5 days after second dose. She experienced cold and hot. She was not complaining at all and she has been sick for days and cannot eat and will throw up but will gain it right back. The dizziness and weakness were subsided. She feels like she is getting beat up but is recovering. Patient thought that vaccine pulled out with a syringe and that's the problem everyone gets the same dose. Patient's weight was 136 or 138 lbs. Outcome of the events nauseated after second dose was resolved on 10Apr2021, and dizzy and weak after second dose was resolved on an unknown date in Apr 2021, and for the events chills and sweating it was recovering, and for all other events, it was unknown.

on the verge of fainting; blood pressure was was 82/48/blood pressure remained low; felt faint/extremely light-headed; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 19Jan2021 06:45 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included hypertension, diabetes (well controlled), and fatty liver disease. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; olmesartan medoxomil (BENICAR); and omeprazole (PRILOSEC); and vitamin B complex. The patient previously took the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Dec2020 06:30 (Batch/Lot Number: EL1284) at the age of 62 years old as single dose for COVID-19 immunisation. On 20Jan2021 09:15, the patient experienced felt faint and extremely light-headed and on the verge of fainting. The patient laid down and then took her blood pressure. It was 82/48. Her blood pressure remained low throughout the day and did not return completely to normal until 3 days later. No treatment was received for the events. Outcome of the blood pressure was 82/48/blood pressure remained low was recovered on 23Jan2021 while of the remaining events was recovered on 2021.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of an association of the suspect drug administration with the reported events, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine.; she can't talk, it's closing up her throat,; she can't talk, it's closing up her throat,; taste sodium in my mouth constantly; coughing; got home and I've been sick ever since.; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration administered on right arm on 07Apr2021 at 13:30 (at the age of 62-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing Allergies with This was under control, ongoing asthma with This was under control, meniere's disease from 1989 and ongoing with This was under control, have 2 broken knees. Patient knows how to control this condition, she didn't need Prednisone prior to onset of these adverse events, Low immune system with She has an immune deficiency so her immune system very low, like 300., Respiratory illness, Genetic/chromosomal abnormalities, Endocrine abnormalities with endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant to AE reported as None. History of all previous immunization with the Pfizer vaccine considered as suspect reported as Both doses of product documented in Pfizer Suspect Vaccine and Vaccination fields. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiry date: 31Jul2021) via an unspecified route of administration to the right arm on 13Mar2021 at 13:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine other than dose 1 of 2 of the Pfizer-BioNTech Covid-19 Vaccine. Regarding concomitant products and other medical conditions patient reported none other than just her inhalers which doses of had to be increased in response to symptoms after first and second doses of Pfizer-BioNTech Covid-19 Vaccine. Concomitant medication included tiotropium bromide (SPIRIVA) taken as Dose increased to twice in the morning daily for an unspecified indication from an unspecified start date and ongoing, (Lot number: 0014678, ; Expiration Date: Jan20230); fluticasone propionate, salmeterol xinafoate (ADVAIR) 500 taken as Dose increased from once daily to twice daily an unspecified indication from an unspecified start date and ongoing; azelastine hydrochloride (Lot Number: 3N2E, Expiration Date: Feb2022), fluticasone propionate (DYMISTA) taken for an unspecified indication from an unspecified start date and ongoing (Lot number: GA00510, Expiration date: May2022); prednisone (PREDNISONE) taken for an unspecified indication with quantity of 27, Dose: 3-20mg daily for 7 days, then 2-20mg daily for 2 days, then 1-20mg daily for 3 days and Ongoing therapy. She also used a nose spray that didn't work so they switched her back to Dymista nose spray. Consumer stated that she received both doses of Pfizer's COVID vaccine and had reactions to both of them. Consumer stated that, "The second dose was even worse. They put her on Prednisone. She did not know if she should be tested again or not? She was sitting up but she could not walk around anywhere. She had 2 broken knees. She could not walk anywhere. After the second dose, they had to bring her to the hospital because she couldn't even walk to her car. She got home and she had been sick ever since. She had allergies too. She could not do anything. she had a hard time breathing. she was hesitant to get the 2nd one, but everybody said to get it. Her IgG level was down to 300 something. She was also tapering off of prednisone and she did not want to be tapering off it because it was worked well for her. She could tell by her breathing that it was helped her. She could taste sodium in her mouth constantly since she had got the vaccination." Second dose completed her prescribed therapy. Dates for Symptoms From 15Mar2021 to Ongoing Reported seriousness for Symptoms reported as Unspecified and the Symptoms was reported as worsened. Patient's doctor dropped her last week, told her she didn't know what to do with her, and that this was too stressful. Onset of symptoms following first dose of Pfizer-BioNTech Covid-19 Vaccine was on 17Mar2021. She couldn't breathe very well when she went in for the first dose of Pfizer-BioNTech Covid-19 Vaccine. She was ok the first day after the first dose of Pfizer-BioNTech Covid-19 Vaccine, seemed ok, arm didn't hurt; but then had onset of symptoms. She has been in bed the whole time since onset of symptoms, was in bed for over 2 weeks. She slept for 2 days straight, only got up for water and the bathroom. It was bad, getting hard to breathe. She had to use her emergency inhaler. The Pfizer-BioNTech Covid-19 Vaccine messed up her Meniere's disease. Doctor started patient on Prednisone for these symptoms, and Prednisone is really the only thing that clears up Meniere's disease because her ears was full and she could not get up. Prednisone helped her and I relayed in her 'rescue' inhalers (treatment) because she did 2 in the morning, two inhalers anyway when she started to feel better, she got her second one and it made her worst. She did not eat anything salty or anything, the barometric pressure was not bad. It was really funny because she had just finished everything and it was a few days before she had to go get her second dose of Pfizer-BioNTech Covid-19 Vaccine shot. She was just starting to feel normal, at least normal for her, she could get up normal and drive. They gave her the second shot of Pfizer-BioNTech and it was like a double. She clarified as she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tasting sodium in her mouth from the Pfizer-BioNTech Covid-19 Vaccine. She can't have much sodium which struck up the Meniere's disease really bad the second day after the second dose of the Pfizer-BioNTech Covid-19 Vaccine; her allergies in her head went bonkers. She could not talk, it was closing up her throat, she was coughing every time she eats or dinks, and she's having a "really bad" adverse reaction to the Pfizer COVID-19 vaccine after the second dose. They had to take her out of the hospital to her car in a wheelchair "right after" getting the second shot. She could not get more than 1000 mg of sodium a day, she tastes it in her mouth constantly, she could not get rid of it and it was "going through her system". She wanted to know what to do, since her doctor told her to contact Pfizer. She wanted to know what part of the vaccine is doing that, she assures it is sodium, because sodium is in her mouth 24/7 and she could not get it out, she could not have that much sodium in her body. It was still getting really hard to breathe. She is still taking the Prednisone she was initially prescribed and started on for the symptoms that started after her first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tapering off of Prednisone, and she shouldn't be tapering off, she thinks she needs to be Prednisone for some more days, maybe 3 more days, then she would be ok. It was prescribed as a 7-day burst of Prednisone. She mentioned that the only Prednisone that works on her is the Actavis manufactured Prednisone; her pharmacy orders it for her because they know that. She called the emergency room Saturday when she was really bad. They said they had a line there and it was going to be at least a 4 hour wait. With patient's low immune system, Meniere's disease and that she could hardly breathe she did not go to the emergency room because she could catch something and die while waiting. She decided she would just stay at home and rest. She has not had any Physician's office visit relative to event; she has a telephone appointment tomorrow to see if the doctor is going to be her doctor. She had to cancel her appointment with the doctor today because if she has something she doesn't want to spread it, she feels worse now and with the Meniere's she is tasting sodium in her mouth constantly from the Pfizer-BioNTech Covid-19 Vaccine, she does not eat a lot of salt. The flu shot takes her a couple of days, then she is right back up and Vaccination Last dose on Oct2020. Consumer stated that she has 'Meniere's' disease (History) and it made her worse. The patient underwent lab tests and procedures which included IgG level: 300. Reporter stated the seriousness for the events was Unspecified. Seriousness of event Meniere's disease aggravated was medically significant. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo and dizziness; really bad vertigo and dizziness; facial palsy; vision in her right eye got fuzzy; face got numb on the right side; hot electrical nerve zinging entire right arm, right shoulder blade and right calf; sore arm; feel sick; hangover; vomiting; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 16Apr2021 11:15 (Batch/Lot Number: EW0162) as single dose (at the age of 62-years-old) for COVID-19 immunisation. Medical history included anaphylaxis: carries an epi pen, and has allergies to wasps. The patient also took unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient got her first vaccine dose on 16Apr2021 and reported having a history of anaphylaxis and carried an epi pen. She stayed at the vaccination facility for an hour and a half and she got facial palsy and her vision in her right eye got fuzzy. Then her face got numb on the right side. It took 4 hours for it to go away but by dinner she felt ok. She added that immediately after the shot (16Apr2021), she experienced hot electrical nerve zinging entire right arm, right shoulder blade and right calf that lasted 30 minutes; blurry vision right eye started 15 minutes after shot, recurred off and on for 6 hours; facial palsy on right side that started about 30 minutes after shot that lasted 4 1/2 hours; vertigo/dizziness that started 7 hours after the shot; and blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85. She filed a report online when her symptoms began to subside. A couple hours later, she began to feel sick again and went to bed. When she walked to her mailbox, she was feeling ok but when she bent over to get the mail, that made it all worse. She woke up feeling as if she had a hangover and reported vomiting right away after getting out of bed. She had really bad vertigo and dizziness. She also had a sore arm (unspecified which arm) and stated that she was "experiencing everything on the freaking list." The patient wanted to know if this was normal and asked if she should get the second dose. She was advised that if she had a severe allergic reaction after a previous dose of the vaccine, she should not get the Pfizer-BioNTech Covid-19 vaccine. She also wanted to know if her symptoms got worse over the weekend and wanted to know what were the signs if she should go to the hospital. The patient did not receive any treatment for the adverse effects. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination. The patient recovered from hot electrical nerve zinging entire right arm, right shoulder blade and right calf 16Apr2021 11:45; face got numb on the right side on 16Apr2021 15:15 and facial palsy on 16Apr2021 16:15. The outcome of the remaining events was unknown.

My nasal passages, throat, and bronchial tubes started to swell up; feeling faint; general malaise; My nasal passages, throat, and bronchial tubes started to swell up; My nasal passages, throat, and bronchial tubes started to swell up; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 62-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 14:00 (Batch/Lot Number: ER8729) (at the age of 62-years-old) as single dose for covid-19 immunization. Medical history included known allergies: penicillin from an unknown date. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 18Mar2021 01:45 P.M. (Batch/Lot Number: ER2613) (at the age of 62-years-old) for covid-19 immunization. The patient did not get COVID prior vaccination and did not receive COVID test post vaccination. About five minutes (as reported) after the patient received the shot, she started feeling faint on 08Apr2021 02:15 P.M. Her nasal passages, throat, and bronchial tubes started to swell up on 08Apr2021 02:15 P.M. Taking a decongestant when she got home helped that. For a few days she had congestion and brain fog along with general malaise. Treatment received included she took decongestants. The outcome of the events was resolved in Apr2021. No follow-up attempts are possible. No further information is expected.

felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.

She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy; body aches; She felt like she was on a boat/ she was not feeling right; had soreness in her arm; has zero energy; She fell asleep in her sunroom and got up around 3:00PM; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158; Expiration Date: Jul2021, NDC not known), via an unspecified route of administration, administered in right arm on 16Apr2021 at 10:00AM (at the age of 62-year-old) at single dose for prevent Covid 19, she wanted to feel safe traveling. No additional administered vaccines administered on same date with the Pfizer vaccine considered as suspect. Medical history included ongoing rheumatoid arthritis and prior to receiving her Covid 19 vaccines she reached out to her rheumatologist to see if she would be ok getting the Covid 19 vaccine while taking her medications, her rheumatologist told her she would be ok to receive the Covid 19 vaccine. Ongoing concomitant medications included methotrexate injection and hydroxychloroquine. No prior vaccinations within 4 weeks. The patient previously was made to get a flu vaccine for work about 20 years before for immunization, the flu vaccine made her violently ill, she ended up having to go to an Urgent Care, she had to call her mother to come get her, she could not even get out of bed, she had to stay home a week from work because she was sick; she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 (at the age of 61-year-old) at single dose for COVID-19 immunization and experienced fever, everything in her body ached, every time she bended over, if her head got below her shoulders to pick something up she would black out and vertigo. When she received her second Covid 19 vaccine her symptoms started again on 16Apr2021. She felt like she would pass out if she didn't feel the black out sensation coming on. She didn't know how long she blacks out for. She tried to grab a hold of something, for example, she was in the shower shaving her legs and she reached down to shave her legs and she could feel herself starting to pass out. She had a ledge or seat in her shower and she grabbed the shower wall and lowered herself to a sitting position on that ledge in her shower. The feeling passed and she tried to shave the other leg and the same thing happened again. When she's sitting on her sofa and she bended down to the floor to pet her small dog, all of a sudden she could feel herself moving forward like she was going to fall forward. Her husband grabbed her arm and pulled her to an upright position and asked her if she was ok. She reported her normal body temperature was 96.9 degrees Fahrenheit on an unspecified date. She was not someone who ran 98.6 degrees Fahrenheit. She reported her temperature had been about 98.8-98.9 degrees Fahrenheit on an unspecified date and that to her was a fever. She was still running a fever. She reported she had been afraid to drive because she was afraid she would pass out. She knew she did not have vertigo. She did a have a yearly check up with her primary care doctor and she was going to talk to her doctor about what's happening. She received her Covid 19 vaccine with her husband at about 10:00AM. Shortly after when she and her husband were driving home, she told her husband she was dizzy on 16Apr2021. She felt like she was on a boat. Even if she looked up or bent over was when she got dizzy. Her fever started right away after her vaccines on 16Apr2021. She also had soreness in her arm and everything in her body aches on 16Apr2021. She had zero energy on 16Apr2021. She was still feeling this way now. She fell asleep in her sunroom and got up around 3:00PM on 16Apr2021. Not any adverse events required a visit to Emergency Room nor Physician Office. The outcome of the event fell asleep was unknown, outcome of the other events was not recovered.

Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; short of breath/I can't breath; am still not well, Bad condition here; am still not well, Bad condition here; dizziness; tired; deltoid starts swelling; lost feeling in my mouth; Left jaw is swollen so huge and it's just hard and now it's going into my lip; my stomach was upset; my jaw was sore; The initial case was missing the following minimum criteria: ICH-unspecified product. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid. A 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 11Mar2021 in left arm at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the context, it was reported that consumer stated, I took the vaccine (Unspecified Vaccine) the first dose on Thursday and right now my left side, they gave it into my left arm and my left jaw is swollen so huge and it's just hard and just like really hard and now it's going into my lip, my lower lip is numb and it's going down into my throat and up in my ear and it's very painful; she was in severe pain. Consumer stated, I took the vaccine 11Mar2021 and next day i.e. on 12Mar2021 I get up and my jaw was sore and then my stomach was upset and then as the day started on my jaw started swelling really big. I took it on 11Mar2021 and I am still not well, Bad condition here, I have lost feeling in my mouth and I can't breath either. It was the first vaccine and this is the very last I am not taking again. Consumer stated, I had a trip to the emergency room. Regarding lab data, consumer stated, No, they documented how swollen was my jaw was, I didn't know I was short of breath until I start back exercising and then I can't breath in there. Consumer stated, Well I just wanted to know how long this is going to last then because I have lost feeling in my mouth. Consumer stated, I got a vaccine back in March and I called Pfizer then because I had, my deltoid starts swelling and I had to go to the emergency room because that's what the paper says if you have facial swelling. So now my deltoid is still swelling, it will go down some and it will start swelling again, I have got numbness in my lips and my chin, dizziness and it hurts. So, I just wanted to know what you can do for that and along with that if it's normal. Consumer stated, Well I have been on hold for an hour, just to get this number, can't you just type the information in have them contact me. When tried to probe for further questions, Consumer stated, I have already documented and I just need to talk to somebody that know what to do to get my job back, like it was. Consumer stated, I went to the emergency room, the paper that they gave it to me vaccine was (name withheld), it's a drive through and they vaccinated it was the first vaccine I got, and I did not go back and get another one because I haven't recovered from that one yet. My face is out swelling up, my lips numb, my cheeks numb and numb. I am just tired and dizzy. The outcome for the events swelling face, lip swelling, hypoaesthesia oral, pharyngeal hypoaesthesia, hypoaesthesia, pain, general physical health deterioration, malaise, abdominal discomfort, pain in jaw,sensory loss, swelling, dizziness and fatigue were not reported and for the event deltoid starts swelling it was reported as not recovered/not resolved. Information about batch/lot number had been requested.

I first felt dizzy and tingling around my lips and mouth about 5-10 minutes after the injection, waited a bit hoping it would go away and when it didn?t we alerted the EMT on site. My lungs sounded ok so I was instructed to go home and take Benadryl. On the way home my tongue began to swell and get a tingling sensation. My cheeks became extremely hot and had a red rash. I ended up having to take two Benadryl to get the symptoms to go away.

Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too sick to call Pfizer yesterday about symptoms; Has a ton of mucous discharge; This is a spontaneous report from a contactable Nurse. A 62-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: JR8729), via an unspecified route of administration, administered in Deltoid Left on 21Apr2021 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6207) on 31Mar2021 for covid-19 immunisation and experienced Sore Arm after first vaccine (Age at vaccination: 62 years). The patient also had a historical vaccine of Flu vaccine on 16Oct2020 for immunisation and experienced Local Reaction; Redness at injection site (Age at vaccination: 61 years). The patient experienced non-stop vomiting for 8 hours on 22Apr2021 02:30, nausea, loose stools, body aches, chills, no fever and too sick to call Pfizer yesterday about symptoms on 22Apr2021, dizzy and weak on 23Apr2021. The patient also stated that she has a ton of mucous discharge on Apr2021. The events were considered as medically significant by the reporter. Outcome of the event vomiting was recovered on 22Apr2021, outcome of the events body aches and chills was recovering while outcome of the events mucous discharge and sickness was unknown. Outcome of the remaining events was not recovered.; Sender's Comments: There is a reasonable possibility that the events vomiting, nausea, diarrhea, and chills were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

right foot is in a lot of pain feels like its broken, barely can walk; right foot is in a lot of pain feels like its broken, barely can walk; This is a spontaneous report from a contactable consumer (the patient). This 62-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in in the right arm in Mar2021 (at the age of 62-year-old) as single dose for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. The patient's medical history and concomitant medications were not reported. The patient previously had blisters on the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7533) via an unspecified route of administration in in the right arm in Mar2021 at 14:30 (at the age of 62-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 03:00 AM the patient experienced her right foot is in a lot of pain feels like its broken, barely can walk. She considered these events resulted in disability. No treatment was received for the adverse events. The clinical outcomes of the "right foot is in a lot of pain feels like its broken, barely can walk" were resolving as of 24Apr2021. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

green stools; difficulty breathing; nausea; headache; dizzeyness; loss of appetite; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: paa156051), dose 1 via an unspecified route of administration, in Arm Left, on 27Jan2021 12:30pm as single dose for covid-19 immunisation. Vacination facility was Other. Medical history included High blood pressure, Low potassium and High cholesterol. The patient had no allergies. Concomitant medication's included Lisinopril, potassium and simvastatin. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. The patient previously reported her adverse events but forgot to add that on 29Jan2021 at 06:00pm she have had green stools since the vaccine along with the 3 episodes of difficulty breathing, nausea headache dizzeyness and loss of appetite this was from wed of injection until friday 9 days later. The patient was terrified of receiving the second dose because these symptoms happened on the 3rd day and later. If she does not take the second dose what are my chances of surviving the virus if she should come down with it. She tried calling and was on hold for 4 hours and no one picked up. Events resulted in emergency room. The patient underwent lab tests and procedures after vaccination which included COVID-19 (sars-cov-2) test: negative on 05Feb2021. Patient did not received any treatment for the events. Outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Her blood pressure went over 220; Migraine; Her balance was off as well; She has been experiencing excessive hot flashes; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included hot flush. The patient's concomitant medications were not reported. Patient mentioned that about 45 minutes after getting it, her blood pressure went over 220. Her normal blood pressure is 132/72 or 74 or 76. After she was released from the ER in the hospital, they asked her to take migraine medications for the migraine she has experienced afterward in Apr2021. She mentioned that she cannot get rid of the migraine and she has been experiencing excessive hot flashes, more than what she was having before. Her balance was off as well. She was asking if this has been reported and for what to do. She was also asking if this will most likely happen during her 2nd shot as well as she was not looking forward to it. She has consulted several doctors already. Patient still have a migraine that has been ongoing for 2 weeks and states it's "not a fun thing." She states she spoke with a neurologist who has gotten phone calls from people who have received Pfizer's and other's COVID-19 vaccines and are experiencing "headaches for days." Caller states that there was nothing medically wrong with her. She states that her blood pressure "never spiked" like that before. She reports that she has taken migraine medication and Percocet for the headaches and was also prescribed Prednisone as a "hope to try to get rid of the headaches." Outcome of the event migraine was not recovered, whereas unknown for other events. Follow-up attempts are completed. Information about lot/batch number cannot obtained.

To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.

Uncontrollable vomiting and diarrhea resulting in severe dehydration and inability to maintain electrolytes with no diagnosable infection to blame. Bed sore from inabilty to move for 14 days until transported by ems.

This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored program. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration in the right arm, on 10Mar2021, as 1st dose, single, for COVID-19 immunisation. Medical history included ongoing fibromyalgia (diagnosed in 1996), ongoing allergies from 1981, ongoing food allergies and chemical allergies, ongoing allergy to alcohol, ongoing hypothyroidism from 2012, ongoing pre-diabetic from 2012, Lyme disease for 11 years before being correctly diagnosed and treated, concussion in Sep2019, and post concussion syndrome in Sep2019. The patient previously took nalbuphine hydrochloride (NUBAIN) in 1981 and experienced anaphylaxis; and paracetamol (TYLENOL) and was very sensitive, had rash and high blood pressure. Within the first 15 to 20 minutes following the administration of the first dose of the Covid-19 vaccine, on 10Mar2021, the patient's face and ears got very red, flushed, and itchy. The patient reported that she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction. She reported that she has had glycol before and has never reacted quite like that. The flushing, redness, and itchiness of her face and ears subsided within an hour and were gone by 4 hours. Her allergist instructed her to take 2 Zyrtec before getting the second dose of the Covid-19 vaccine. After her face and ears became flushed, red, and itchy, she ended up having a really bad headache that continued until the next day. Her headache was severe for about 12 hours and continued for a total of a day and a half. She stated that her headache was more like a migraine during the 12 hours when it was severe. It felt like a migraine, but worse. On 10Mar2021, the patient reported that she experienced flu-like symptoms like being nauseous, had dizziness, achiness all over, and was not feeling well, her post-concussion syndrome was triggered and had more headaches, dizziness, nausea. She reported that things have been going awry in her body since she had the COVID-19 vaccine. She reported that the increase in headaches seemed to have improved, but the nausea and dizziness have in some ways improved and then some days it feels like "here we go again" when it hits. About a week after she received the first dose of the Covid-19 vaccine, in Mar2021, the patient noticed a change in her urination. It wasn't severe or anything at that point, she just felt like she was not able to release the urine (urine retention). She thought to increase her intake to see if it would help her urinate and it didn't seem to help much. She received a prescription on 26Mar2021, and during that week, she noticed that she was having more issues with some burning during urination and was developing pelvic pain and pressure. The patient stated that the scent and color of her urine looked fine. She reported that the frequency started to increase with not much urine coming out. When she finished her antibiotics about 7 days later, the urine retention had really improved and went away at the end of March. In the morning of 26Mar2021, when the patient woke up, she had blood in her urine and clots. The clots were about the size of a pea and a couple were about the size of a dime. The blood and blood clots in her urine were what made her go to the doctor. She reported she has never had blood in her urine that she remembers. She was put on Macrobid for 5 days. She reported that Macrobid wasn't relieving enough of her symptoms and her provider ended up adding a couple more days. The patient reported feeling more worn out in Mar2021, since she received the first dose of the COVID-19 vaccine. This did not improve and some days it was worse. The patient did not have the energy level and stamina that she used to (Mar2021). She reported that whether it's combined with the retriggering of her post-concussion syndrome, it is significant for her life. She was also not eating well and had lost some weight (Mar2021). She reported that her appetite is improving but it is still not normal for her. She mentioned it was harder for her to want to eat something because of feeling nauseated. The patient assessed the events "face and ears became very flushed, red, and itchy", headache, "headache was more like a migraine/felt like a migraine, but worse", "post concussion syndrome was retriggered", "blood in her urine and clots", "not eating well and had lost some weight" and "feeling more worn out" as serious (medically significant). The patient recovered from "face and ears became very flushed, red, and itchy" and "she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction" on 10Mar2021; headache, "headache was more like a migraine/felt like a migraine, but worse", "she was not able to release the urine (urine retention)", "blood in her urine and clots", "flu like symptoms", dizziness, "achiness all over", "pelvic pain and pressure", and "some burning during urination" in Mar2021; and was recovering from "not eating well and had lost some weight". The outcome of the remaining events was unknown. The patient assessed the causality of events headache, flu like symptoms, nausea, "face and ears became very flushed, red, and itchy", dizziness, "post concussion syndrome was retriggered", and "not eating well and had lost some weight" as related to BNT162B2.; Sender's Comments: Based on the information in the case report and a plausible temporal association, A possible causal relationship between urinary retention, hemorrhage urinary tract and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

severe arm pain; Nausea; Dizziness; klebsiella pneumoniae, 50,000 to 100,000 cfu; Headache; Urine retention; blood and blood clots in her urine; blood and blood clots in her urine; tore or messed up a ligament in her hand; This is a spontaneous report received via a Pfizer-sponsored program, from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported), via an unspecified route of administration, administered in arm right on 31Mar2021 (at the age of 62-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included fibromyalgia from 1996 and ongoing, allergies from 1981 and ongoing, hypothyroidism and is pre-diabetic from 2012 and ongoing, Lyme disease from an unknown date and unknown if ongoing, concussion from Sep2019 to an unknown date, post-concussion syndrome from Sep2019 and ongoing , seasonal, food and chemical allergies from an unknown date and unknown if ongoing and had wisdom teeth extracted on an unknown date. The patient's concomitant medications were not reported. The patient previously took nalbuphine hydrochloride (NUBAIN) and experienced anaphylaxis. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EN6206), administered in right arm on 10Mar2021 for COVID-19 immunisation and experienced Face and ears became very flushed, red, and itchy, Headache, headache was more like a migraine/felt like a migraine, but worse, Post concussion syndrome was retriggered, not eating well and had lost some weight, feeling more worn out, she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction, flu like symptoms, achiness all over, pelvic pain and pressure, some burning during urination, did not have the energy level and stamina that she used to, blood in her urine and clots, she was not able to release the urine (urine retention), Nausea and Dizziness. About a week after receiving the second dose of the Covid-19 vaccine on 31Mar2021, she noticed the feeling again of retaining the urine. She was not swollen or anything and immediately went with increased fluids. The urine retention was not as severe at that point. It really showed up and intensified quickly with groin pain, pelvic pain, abdominal pain, and some back pain. She woke up the next morning after being doubled over in pain the night before and there was so much blood in her urine that she couldn't see any urine. Her urine was the darkest burgundy and the color of the darkest wine. She did not have anything in her urine the night before when she was doubled over in pain. She was increasing fluids and even drinking Propel for the electrolytes to make sure she was not making things worse. She woke up around 5 AM and felt so sick to her stomach. She had nausea the night before, but she was really nauseated the morning that she discovered blood in her urine. She woke up with severe nausea last Friday, 30Apr2021. Her doctor performed a urine culture. The urine culture returned positive for Klebsiella Pneumoniae with 50,000 to 100,000 CFU/mL on 30Apr2021. She does not have the urine culture results from her first doctor visit. Her friend is an RN that is administering the Covid-19 vaccine, was talking to company representatives and told the caller that she needed to call company to make a report and see if anyone else has experienced the same adverse events. Urinary retention came back in Apr2021 following her second dose of the Covid-19 vaccine on 31Mar2021. She can really go to the bathroom, but she is still feeling the abdominal and pelvic pressure as well as some burning and pain. Her symptoms are improving but not enough. It feels like she always has a full bladder still. She tore or messed up a ligament in her hand and she has been going to occupational therapy. She can't seem to be able to handle a pain level like she used to. It seems like pain is triggering her feelings of nausea and dizziness. Her body is not doing things well right now. The day before, of, and after getting the Covid-19 vaccine, someone suggested taking electrolytes before the second dose of the Covid-19 vaccine, so she drank Powerade. She was expecting the symptoms following the second dose of the Covid-19 vaccine to be a lot worse and they were a walk in the park in comparison. She had a mild headache the first day, 31Mar2021. She woke up in the morning of 01Apr2021 and her headache was gone. Following the second dose of the Covid-19 vaccine, she had severe arm pain. It felt like she was walking around with someone constantly punching her. She was moving her arm all around trying to get it to stop hurting. She saw blood and blood clots in her urine for over 24 hours. The blood and clots were lessening over the 24-hour time period. She probably saw in a 2-hour period at least 60 clots about the size of a quarter to a half dollar. The pain was excruciating. She was taking Phenazopyridine but is still feeling a sense of urgency, burning, and sometimes pain during urination. Her doctor did give her a prescription for phenazopyridine, but it was cheaper for her to buy over the counter and take the same dosage. She has been taking generic Macrobid, Nitrofurantoin Mono, 100 mg twice daily. It was dispensed in a pharmacy bottle. She is seeing a urogynecologist tomorrow, 06May2021. The patient underwent lab tests and procedures which included culture urine: unknown cfu on 26Mar2021 and culture urine: klebsiella pneumoniae, 50,000 to 100,000 cfu on 30Apr2021. The outcome of the event Headache was recovered on 01Apr2021 while of the rest was unknown. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

HYPERtension, Syncope Hx. HTN and did not take BP meds in the morning. also anxious about immuniation. Narrative: History of recent stress test with pending results. pt. c/o lightheadedness while seated in recliner during observation. Per pt., she feels anxious after witnessing another person have a syncopal event. BP 240/98, P 76, R 22, O2 sat. 99% at 0935. RRT in the area so they assessed the pt. and convinced her to go to ED to be checked out. D/c'd per w/c to the ED with RRT. ED reported BP 190/108 in the ED. States she did not take BP meds in the morning and was anxious about her immunization today. ED reported she took her Losartan at 4pm. Discharged from the ED. Recorded on employee medical file on database.

Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vaccination; I experienced muscle soreness at the site of injection; mild fatigue the next day (12/14/2020). After the second vaccine, I experienced increased muscle pain, with decreased ROM of the left shoulder due to pain. Within 12 hours, I experienced diffuse myalgias. After 16 hours, I experienced a fever (101F) with chills (resolved within 24 hours). There was significant fatigue the first 36 hours after the second vaccine administration. I took two doses of Tylenol on the first day. No rash.

20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83. Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.

Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. I am awaiting an appointment with my primary care physician and will know then if more treatment will be recommended. Incident Report filed at the hospital.

Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine was administered. The tachycardia resolved without medical intervention within 2 minutes. The remainder of the symptoms remained the rest of the day, along with profound fatigue and intermittent self limited tachycardia. The headache was managed with Tylenol. I slept most of the day and through the night. The following day, I had a headache, which was mild. Fatigue remained. I also noted intermittent tachycardia with mild exertion, self limited, less than 1 minute. Mild soreness at injection site.

I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I have had these symptoms for 12 days, unchanged. I cannot work because of these symptoms. I have been to urgent care and have had lab work and an EKG

She reported a mild lightheaded feeling. Declined a visit from the doctor. States has this feeling often and is not certain if it is anxiety or related to the vaccine.

up a lot during the night after vaccination, lots of body ache, temp 100.2 dizziness during the day on 1/12

Extreme fatigue. Had to sleep. Slept 2 hour nap, 9 hour night, then two more two hour naps. (6-7 hours is normal sleep time for me) Groggy and dizzy during that same time when awake. Resolved within 32 hours.

horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches and restless sleep, bad dreams. Next day headache, significant fatigue and body aches. Emotional feelings like I wanted to fry ( I am not a crier). 2 Nd night restless sleep, bad dreams, headache. Next day brain fog and significant dizziness and vertigo.

malaise; headache; low grade fever; dizziness; overall body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided as unable to locate or read the details), intramuscularly on 08Jan2021 at 10:30 AM on Left arm at single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided) intramuscularly on 18Dec2020 at 10:15 AM on Left arm at single dose for COVID-19 immunization at age of 63-year-old. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced malaise, headache, low grade fever, dizziness, overall body aches on 08Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the Lot/batch number has been requested.

She states that she felt lightheaded and that her vision "went black" for about 10 seconds, during which time she was standing and holding on to her husband, and then quickly recovered spontaneously and subsequently felt fine. Has had a previous history of this adverse event with previous injections. Namely the allergy shots she gets from her allergist.

within 24 hours vaccination shots, I had intermittent low grade fever, constant chills, and mild VERTIGO (that was the worst). Re the Vertigo, I didn't fall but experienced it whenever moving. I was bumping into walls and was dizzy whenever I moved position (e.g. sitting to standing & vice versus). These symptoms lasted 5-7 days after they began (both shots).

2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I was so dizzy I couldn't open my eyes without getting sick. We called ER and explained that we thought I was having a reaction to the vaccine, and their response was they had never heard of that type of reaction. I was sick all night, called my primary Dr in the am and they told me to go to ER. We had to call ambulance to take me there because I was so sick and couldn't open my eyes without having to vomit. Room spun in circles. My arrival at ER, they did MRI, EKG, blood work. My blood pressure was very high, so they connected me to a heart monitor. I had low Magnesium due to vomiting so much. I was treated with Valium and anti-vert medication and fluids. I stayed overnight in hospital- had PT Jan 13th for DX of Vertigo. Then referred to Outpatient PT for Vertigo. Dr's felt it was a "coincident" that I got Vertigo shortly after vaccine, and strongly felt it was not related. . Today is Jan 17th, and I am still dizzy, but feeling better. I have an appointment with my primary Jan 18th and not sure if I should take the 2nd dose. That is the question.

12/29 vaccine 10:45. Twenty minutes after vaccination, breathing fast, stiffness in L neck. L sided weakness; transported to ER. I couldn't lift left leg, 1" off bed and couldn't do the push pull. 1-2 hours symptoms lasted. Everything went back to normal, sent home. 12/30 huge flare up with fibromyalgia; lasted couple days. Flare up occurred the following week. Getting second shot 1/19/2021

Injection was administered very high on left arm(at joint level). It felt like a nail went in, and then she pushed in the medicine. Just the injection process alone made me feel ill. So I waited the 15 minutes before I left, until I felt safe to drive. At noon the meds started affecting me, which is what I expected. I've continued to experience arm pain, weakness, armpit swelling and tenderness, arm not wanting to work and posturing. This is day four and its just starting to feel like its coming back "online." Monday I reported to Colleague Health, who advised me to contact my physician, who I consulted via phone this morning. Physician requested I fill out Adverse Event form.

Coughing/cough has worsened; Tiredness; Sinus congestion; Runny nose; Dizzy; Didn't feel well; Sneezing; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 09Jan2021 (11:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at a clinic (not a military facility). Medical history included ongoing rhinosinusitis from 2019; ongoing allergy multiple; bronchitis from Mar2020; upper respiratory tract infection from Mar2020; sleep apnea; bipolar depression; and post-traumatic stress disorder (PTSD). There were no concomitant medications. On 09Jan2021 (06:00), the patient had sinus congestion and runny nose. On 09Jan2021, the patient was dizzy. On 10Jan2021, the patient was coughing, and then cough was reported to have worsened; and had tiredness. In Jan2021, the patient did not feel well; and was sneezing. The patient had used a nose rinse with an alcohol rub, and took and Epsom salt bath, and had some soup as treatment for the sinus congestion and runny nose. The patient had two COVID-19 virus tests on unspecified dates, and both were labeled as inconclusive. The outcome of the events was not recovered for 'sinus congestion', 'runny nose' and 'cough/cough has worsened'; and was unknown for 'dizzy', 'tiredness', 'did not feel well' and 'sneezing'.

As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I couldn't lift my arms and once I closed my eyes, I could not muster the strength to open them. I felt like I was going to faint and then I got nauseated and I knew I was going to throw up. With my husband's help, I did manage to get to the bathroom (about 6 steps away). I threw up and immediately sat down in the nearest chair. I threw up a second time into a vessel after that. I then got a massive headache and chills. I could barely walk with assistance up the stairs to go to bed. I have never been more fatigued. After going to bed, I slept all night and woke the next day still fatigued, but nothing like the night before. I was able to work, even though I felt really tired. I did not have much of an appetite all day and two days later, I still feel fatigued.

hives covering entire body including soft palate, headache, body aches, stiff joints, fatigue Depo medrol injection, Prednisone 20 mg/day X 4 days; Zyrtec X 12 days, Benadryl X 12 days

Evening of both doses I had nausea which went away overnight, (also had very strange dreams with frequent waking up which might have had nothing to do with the vaccine). Second dose nausea the first night, extreme fatigue the second day which was gone by day 3. Headache from day after vaccine until today (5 days later) with more severe headache and dizziness today, but not bad enough to make me not be able to function.

Chills for 3 hours and than abnormal gait which got so bad that became unable to walk for 10 hours without falling down. At first had to hang on to things to walk and than unable to stand or sit up- felt like I was being pushed backwards. Emesis all day

Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. Incident Report filed at the hospital. MRI done on 1/20/2021-saw Doctor on 1/22/2021 who diagnosed adhesive capsulitis.

Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.

Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extreme pain lasted from 0140- 0500, but continued with the skin tenderness, chills, headache and joint pain. Took Tylenol. Got up once and thought I would pass out. Started resting some around 7am. Drank plenty of fluids. Drained all day. Saturday morning headache, nasal congestion, joint pain, hard to get out of bed. Drained all day. Sunday feeling better, but lethargic. Monday back to work.

Woke up on 1/26/21 with aches which lasted until 1/27/21. After I got up I had loose bowel movements approx. 15-20 mins apart for approx 2 hours. Felt nausea upon waking and for 2-3 hours. Became dizzy about 1 1/2 hour to 2 hours after waking. Duration of dizziness approx 1 hours. Tired all day. 1/27/21 woke up with all symptoms gone. New symptom was swollen lymph gland under right arm and very sore. Duration 3 hours so far. Will call primary doctor.

: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning neck with stiffness . 2nd day Chills, headache. Joints are in pain along with other body pain, nausea. Now, fever 99.1. 3rd day is today, 01.27.21, voice is affected, fatigued body is very achy.

Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been experiencing extreme fatigue. On Sat. around 5:00 PM she was standing at her flat-top stove cooking dinner. A wave of very extreme fatigue came over her, so she leaned over to turn off the burner. When she did this, she passed out leaning forward with her hand on the burner and touching the frying pan. When she came to, she went to the couch and laid down - not realizing for 10 minutes that her hand and right breast were burned. The resulting injuries lead to her having to see her PCP on Monday, and then a General Surgeon on Weds 1/27/21. Injuries sustained include a second degree burn on her right breast, On the right arm, laterally above the wrist is a small superficial partially healed burn. On the dorsal aspect of the right fifth finger there is a longitudinal burn that goes from the MCP joint to almost the tip of the finger. She has limited range of motion due to discomfort and swelling. The blister encompasses the entire dorsal lateral aspect of the finger. The fourth right finger has a less extensive blistered area on the PIP joint. The burn on the fifth finger is deep second degree.

Vertigo for 2 hours- stayed low to the ground so I wouldn't fall. It's been 3 days since my vaccination and I still feel slight vertigo once in awhile Blurred vision for 2 hours Nausia for 2 hours

starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved - now dizzy when standing; fatigue - arms feels heavy when taking shower; pale; remains very weak and tired; dizzy - feels like anemia - tried to work last night but broke out in cold sweat and pale so sent home from work last night - sxs are not worsening

Driving home on the 28th she started feeling dizzy, shaky. She says she feels fine when she is lying down, but not when upright. She called her doctor and they told her to monitor her symptoms and call if she got worse.

2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redness at site of injection

Patient reported feeling dizzy and passed out at home when she was alone. She was able to call a friend when she woke up. The friend came to pick her up and drove her to the patients primary care physician. The physician found all labs and vitals to be normal and told the patient to return home and rest.

The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.

Scattered dizziness and nausea; Scattered dizziness and nausea; This is a spontaneous report from a contactable nurse, the patient. A non-pregnant 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration in the right arm, on 13Jan2021 at 07:00 AM (at the age of 63-year-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol, regurgitation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT), rosuvastatin calcium (CRESTOR), omeprazole (PRILOSEC). The patient previously took erythromycin and experienced drug hypersensitivity. The patient has allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), right arm on 23Dec2020 for COVID-19 immunization. On 15Jan2021, the patient experienced scattered dizziness and nausea. The patient did not receive any treatment for the events. The clinical outcome of the scattered dizziness and nausea was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

odd taste in her mouth; arthritis; Yesterday I couldn't walk, my hip hurt me so bad. It still hurts now; Yesterday I couldn't walk, my hip hurt me so bad. It still hurts now; Yesterday I couldn't walk, my hip hurt me so bad. It still hurts now; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL3246), via an unspecified route of administration on 18Jan2021 around 7am in the right arm at single dose for COVID-19 immunization in hospital. Medical history included her hip usually bothered she, she could stand up, took a second then she could just go and put weight on it, and it would hurt the patient if she had been sitting for a long time. Family Medical History Relevant to AE was none. The patient's concomitant medications were reported as none. No history of all previous immunization with bnt162b2 considered as suspect. No additional vaccines administered on same date of bnt162b2. No prior vaccinations within 4 weeks. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140) on 28Dec2020 in the right arm at single dose for COVID-19 immunization at the age of 63-year-old; first dose of shingles shot (varicella zoster vaccine) for immunization; with the second shingles shot she had a reaction, not the first, it was the varicella zoster vaccine rge (cho) (Shingrix) and was done in 2019 for immunization. It was reported that patient got her second vaccine this morning (18Jan2021) and after eating lunch she had an odd taste in her mouth. She didn't think that was a side effect but want to check and make sure. She questions whether this was a side effect or in her head. It was still going on but not as bad as it was, it might be her imagination. Patient remarked that the more she was talking the better it was getting, the odd taste in her mouth. This event was not required a visit to Emergency Room or Physician Office. Patient further reported that several hours after having her shot on 18Jan2021 she had a problem with her left hip. A while before she had a doctor told her she had arthritis on 18Jan2021 and then another doctor told her that she didn't. When her hip usually bothered she, she could stand up, took a second then she could just go and put weight on it. And it would hurt her if she had been sitting for a long time. But this time it's lasting a long time. 18Jan2021 she couldn't walk, her hip hurt so bad. It still hurts now. She could stand up, but she couldn't put weight on it. 18Jan2021 her symptoms when she ate something, she got a really weird taste in her mouth. When she ate her lunch 19Jan2021, she didn't feel quite right so she stopped eating. She came back to her food a little later and everything was fine. Patient clarified that the weird taste in her mouth form 18Jan2021 has resolved. No investigation assessment. The outcome of event odd taste was recovered on 19Jan2021; outcome of the other events was unknown.

Systemic: Other- 1/28 early morning visual disturbance, lost balance and fell,lasted until mid day wednesday 1/28

8:20 pm - Patient received Pfizer COVID-19 dose 2 vaccine at 3:41 pm. Came in to c/o severe headache, dizzy, vomiting, and chills. BP high initial 176/81 P: 76, 97.7, O2: 99%. Patient has hx of HTN ans took medicine in the am. IMT called 8:25 pm, assessed vitals retaken (BP: 189/84; P:82 right arm; BP: 188/86, P: 82 left arm, and transported via wheelchair to Emergency Center for evaluation.

Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Joint pain one day after vaccine Fatigue one day after vaccine Foggy, light headed feeling one day after vaccine Headache and fatigue day 2 after vaccine

Patient started complaining of tongue swelling, same as when she had an anaphylatic reaction to strawberries. Patient was given 1 epi pen at 11:07am in the left thigh at the clinic. EMS transport Patient is a 63 y/o F with h/o environmental allergies and asthma who presents to the ED via EMS for evaluation of an allergic rxn that began at 1030 today. Pt was at hospital and had just received her first COVID vaccine when she developed a facial rash and swelling to her tongue and throat. She also c/o dizziness. She was given Epi, Solumedrol, and Benadryl via EMS with improvement. Pt currently receives an allergy shot monthly for tx of her environmental allergies. She has never used an Epi pen previously. Pt denies fever.

Fever to 101 beginning about 5 hours after injection. Followed that evening by nausea. Fever and nausea persisted all night. Sat AM 1/30/2021 fever had broken, nausea persisted. After a couple sips of tea, returned up stairs to go back to bed: Sudden complete loss of consciousness (syncope), striking right forehead on wooden chair as falling to the floor. Completely unresponsive for 5-10 minutes. Then confused but responsive to voice. Amnesia for events for at least the next hour. Taken via ambulance to ER for evaluation. Trouble with concentration and dexterity for nearly a week. Bruising and tender forehead for more than a week. Left arm injection site became red and itchy 1/31/21, for several days.

Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the muscle group was sore. The next morning I was dizzy, lightheaded, mild headache, nausea, chills. It went all throughout the day. I just drank some clear liquids and ate some soup. When I woke up the next day about 36 hours after receiving the vaccine I had low energy, nauseous, and lightheaded . By that night my arm started feeling weird, it had a tinging feeling, I went to look at it the mirror and there was a red area and bumps but it was lower under the injection site. It seemed to get worse, swelling and more rash so I took Loratadine 10 MG (antihistamine). I went to bed and when I woke up this morning the rash was gone but the soreness is still there and the tinging feeling in my arm is still there. It feels like when your arm falls asleep. I tried to called my doctor but their phones are down and I will try reach back out this afternoon.

Report from assisted living. starting 2-15-2021 Client was confused. UTI ruled out. She was wandering places she should not. She was in another residents room. She is speaking to staff in another language. VERY confused. Trying to eat her napkin. Unable to dress herself. 2-16-2021 incontinent. not normal for her. unable to stand up. very weak. still very confused. left arm pain. falling asleep mid sentence.

Sudden numbness, dizziness on and off, numbness receded. Pt encourage to stay but refused and left facility. Instructed to follow up with PCP. 1520 BP 108/58, HR 76, OSat 98% 1540 BP 110/64, HR 76, OSat 97%

Pt reported feeling "woozy" w/ "tunnel vision" whileamb w/ PT to observation area. Pt immediately sat in chair at 9:10am w/ BP 149/82 and HR 74. Pt then t/f to stretcher and placed in supine position. VS cont to be monitored:9:33 - supine - 146/84, 67 denied symptoms c/o "tunnel vision"9:49 - supine - 138/81, 68 denied symptoms 9:55 - pt sat at EOB and denied symptoms pt was givenwater and crackers w/o issue 10:12 - standing - 132/90, 80 denied symptoms, pt amb across room and back (about 50') w/o LOB or sx

Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot: EL1284/expiration date not provided) via intramuscular route of administration, in left arm, on 19Jan2021 (at the age of 63 years old) as a single dose for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included losartan, amlodipine, metoprolol, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date not provided) on 29Dec2020 (at the age of 63 years old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021, the patient experienced nausea, chills, body aches, lightheadedness, trigeminal nerve disorder. On 22Jan2021, the patient was diagnosed with trigeminal neuralgia. The events resulted in a physician office visit and Emergency Room visit. The seriousness criteria was disabling/incapacitating. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. Treatment received for the events included steroids, anti-convulsant and pain relievers. The outcome of the events was not recovered. Follow-up (08Feb2021): New information from a contactable nurse (patient) includes: new event (trigeminal neuralgia), event details, seriousness criteria, treatment received and events outcome.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, nausea, chills, body aches, lightheadedness, trigeminal nerve disorder, Trigeminal Neuralgia and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Pt complained of throat tightness and being lightheaded beginning at 1127 hours (5 minutes after vaccine). She arrived at emergency/symptoms reporting station at 1129 hours. She denied tongue swelling, denied rash, denied difficulty speaking. No rash was seen by medics either. Pt did not have wheezing or stridor. Medics on scene and student medics under the direction of Medics, placed the patient on the monitor. Her HR was stable in the 70s and her sats were 99-100% on room air, with a strong pulse and RR of 16. The pt became more anxious and demanded that someone assist her with her Epi pen administration. RN explained sxs of anxiety and sxs of anaphylaxis. Pt became agitated and again remained adamant that medics give her Epi. At 1132 hours a student medic under the direction of Medics administered the pts own epi pen to her. Vitals signs after epi were HR of 88, BP of 170/97, RR 22, sats 100% . A transport unit was called as precaution and to potentially transport. Pt appeared to have an increase in agitation as indicated by her speech with medics being short and her stating that she was "irritated" with "everyone talking", that she "can't hear everyone all at the same time", that this is just "too much" and waving her hands in the air. Pt was transported to the ER via Medics for continued care and follow up.

The injection was at 10:06am. At 10:07am felt nauseated and dizzy. Waited 15 minutes before proceeding home. At 10:31am throat began to close and tongue became swollen. Lips and gums were numb. Breathing became difficult as was swallowing. Rapid heartbeat. Called 911. Pt was taken to the hospital. Administered Benedryl and possibly a steroid. Stayed overnight in the hospital.

Sharp shooting pain down arm at time of injection. Subsided quickly and then 20 minutes later arm got sore, painful to lift or move around. Icy feeling and aching when arm is quiet. Painful to rotate shoulder. Some dizziness and lightheadedness.

Chills, 102°, headache, body aches, extreme fatigue and injection site pain Symptoms began within 45 minutes lasted 48 hrs , treated with Tylenol. Unable to get out of bed.

(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST AND IT IS NOTED THAT PATIENT HAS PREVIOUS ISSUES WITH FLU SHOT WITH A HISTORY OF TORUBLE BREATHING. TEACHING IS PROVIDED WITH PATIENT REGARDING POSSIBLE SIMILAR REACTIONS WITH COVID-19 VACCINE AND THAT SHE SHOULD STAY AT LEAST 30 MINUTES AFTER VACCINATION IF SHE WISHES TO PROCEED. PATIENT CONSENT TO PROCEED WITH COVID-19 VACCINATION. VACCINE IS GIVEN AT 1000 INTO RIGHT ARM AND PATIENT IS ASKED TO STAY FOR OBSERVATION. AT 1030 PATIENT REPORTS TO THIS NURSE ITCHING AND HIVES. PATIENT IS OBSERVED TO HAVE HIVES COVERING BILATERAL ARMS AND CHEST. PATIENT DENIES BREATHING TROUBLE AT THIS TIME. EMERGENCY REACTION KIT IS BROUGHT TO PATIENT?S TABLE. AT 1032 ON CALL PROVIDER IS NOTIFIED OF REACTION AND ORDERS ARE GIVEN FOR BENADRYL 50MG IM. THIS IS GIVEN AT 1034 RN INTO GUTEAL AND PATIENT IS OBSERVED AND VS OBTAINED. AT 1040 PATIENT STATES HER THROAT FEELS ?SCRATCHY? AND ?TIGHT.? IT IS RECOMMENDED TO PATIENT SHE SHOULD BE SEEN IN THE EMERGENCY ROOM. PATIENT AGREES TO THIS IF SHE IS ABLE TO DRIVE HERSELF. PATIENT IS FOLLOWED IN HER VEHICLE TO EMERGENCY ROOM FROM OFF-SITE CLINIC (APPROX. 8 BLOCKS). ON CALL PROVIDER IS NOTIFIED AND HOSPITAL EMERGENCY ROOM IS GIVEN REPORT FROM THIS NURSE. UPON ARRIVAL TO ER PATIENT IS SEEN PER MD. PATIENT REPORTS SYMPTOMS OF CHEST PRESSURE, DYSPNEA, LIGHT HEADEDNESS, ABDOMINAL PAIN, RASH, REDNESS, WARTHM AND ITCHING. PATIENT IS GIVEN 0.4 MG SUBCU ADRENALINE AND 40 MG PREDNISONE ORALLY. PATIENT IS OBSERVED IN EMERGENCY ROOM x 1 HOUR. PATIENT REPORTS SHE IS STARTING TO FEEL BETTER. PATIENT IS DISCHARGED TO AT 1206 FROM EMERGENCY ROOM.

got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.

Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Dose potentially administered too high but patient didnt bleed. Banaid placement described as one finger width below acrimion bone. Immediately \u2026 at the time of injection \u2026 shooting nerve pain radiating down the arm into fingers. Pain became a hot tingle over the next 15-30 minutes. Impaired right arm mobility and range of motion \u2026 shoulder pain with motion beyond a modest range. Three days later still experiencing some pain with certain arm motions \u2026 primarily raising arm above shoulder

Complaint of dizziness and feeling warm. Alert and oriented x 4. Respirations even, skin within normal limits. Denies shortness of breath, chest pain and palpitations. BP 122/60, P 84, O2 94%, R 16. Patient states that she was feeling dizzy before she came in to clinic and that she had not eaten anything. BP 124/64, P 84, O2 95%, R 16. Patient discharged from clinic.

COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot nausea Day four of shot back and joint pain Day five of shot sick feeling aching all over. Muscle and joint pain and fatigue. Chest pressure, cough, Hoarse voice Day six of shot headache fatigue pain through right eye. 2/5Temp 96.6, 98.6, 1:00pm SPO% 93% Resting heart rate 90 6:30pm SPO% 89%-91% Resting heart rate 102 Tylenol 100 mg 9:00am, 3:30pm TEMP 4:30pm 99.7* Symptoms of the freezing chest and cough as well as headache and feeling poorly kept rising several times a week. Covid 3/1/21 Covid symptoms return just like after Covid 19 1st vaccine. Body aches, joint pain, Chest pain, muscle aches, frozen feeling in lungs, cough, abdominal pain,eye ache, headache and fever. Temp 95.5 SPO 89% - 94% Resting heart rate 92 - 95 (After Covid shot 89%SPO, RHR 105, temp 99.7) 12:25pm temp 99 2/2/21 Feeling a little better. Still fatigue and ill feelings. At nighttime cough comes back with freezing lung feeling. Also started and body aches and joint stiffness. Went to bed took ibuprofen. 2/3/21 Still feeling ill . Woke with productive cough a little looser. Headache fatigue just feeling crummy.

Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions. Pt told to stay 30 minutes for observation. During observation patient reported feeling itchy. VS taken at clinic and were stable: HR 88, BP 135/66 Spo2 94%. Patient's face was slightly red without edema. She reported breathing okay but felt a little tight in her throat. Sent to ER for management. Per ER note "63 year old female with a complex medical history including lupus, scoliosis, Sjorgen's syndrome, and anaphylaxis requiring intubation presents complaining of itching and dizziness following COVID 19 vaccination with the Pfizer mRNA vaccine...patient's exam demonstrates itchy red welts consistent with urticaria and she endorses a foreign body sensation in her throat. Examination of the oropharynx demonstrates uvular edema without stridor. The patient endorses chest tightness but does not have wheeze on exam...endorses nausea. Diagnosed with anaphylactic reaction. Patient received epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV along with albuterol MDI. Had improvement in symptoms within an hour, observed for 6 hours without recurrence of symptoms and was discharged home. Advised not to receive second dose of vaccine until discussion with allergist occurred.

It was the Pfizer Vaccine. I received the vaccine at 11:30 am Sunday. At approximately 3:30 pm I started having a lot of pain in my legs (calves and feet) at first it was extreme pain that led to tingly prickly sensations. I went home, went to bed, was up all night in bed groaning because of the pain, and when I tried to stand, was unable to. I crawled to my phone and called my sister (who lives next door) who ran over. She has a wheelchair and took me to the hospital. I was unable to walk alone for four days and the pain was not as extreme after 5 days. I am now 3 weeks out and still have numbness in my legs.

Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cleared up after several hours.

2:40PM 'TONGUE FEELS NUMB AND LIGHTHEADED'. DENIES ANY SOB, DYSPNEA OR DIFFICULTY SWALLOWING. STATES SHE CAN'T TAKE BENADRYL. SPEECH CLEAR, A/O, NO CYANOSIS, W/D, RESP REG WITH EASE. NO ACUTE DISTRESS. SIPS OF WATER AND COMFORT GIVEN. 3PM 'FEELS BETTER NOW'. 3-5-21 3:30PM 'FEELS BETTER TODAY - LEGS ACHE SOME'.

Patient finished observation, then suffered a seizure and fall on the way out of the clinic. Paramedics were called and the patient was monitored and transferred to the hospital on site

Severe pain at injection site, unable to raise arm above 90 degrees of shoulder flexion without the assistance of the opposite arm.

Patient stated she felt nausea. Later became lightheaded and had to be transported to the Emergency Department.

2021-00015215 The patient felt dizzy after her first injection, and also today after her second dose of Pfizer. She refused medical treatment and we kept her in rcovery for 45 minutes. All vitals monitored were within normal limits. She signed and against medical advice form and her husband drove her home.

extreme dizziness, nausea and vomiting for 9 hours fast heartbeat, palpitations for 9 hours overlapping headache

Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very severe dizziness and lightheaded.

Patient started to have mild queasiness about 20 minutes after vaccine was given. Within a few minutes of the queasiness, patient started to feel dizzy and nauseous. Patient endorsed feeling "not quite right". Patient was brought over to paramedics for further observation. VS taken over the course of ~1 hour prior to patient being transferred to ED. Transport occurred on date of vaccination. On post-vaccine Day #1, pt continued to endorse some dizziness. Also noted to have SOB, headache, and mild body aches with a brief episode of chills. On post-vaccine Day #2, pt still felt SOB, more upon exertion. Pt had to use rescue inhaler every 4 hours, which helped pt "breathe and relax a little bit."

Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she would step down; Loss of appetite; She slept all day; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264B), intramuscular on 01Feb2021 at single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on 11Jan2021 for COVID-19 vaccination. Caller was a consumer that was calling about the Covid-19 vaccine and said that she wanted to report her symptoms after the Covid-19 vaccine. Caller reported that she experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain on, fever, feeling unwell, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day on 01Feb2021, swollen lymph nodes on her neck and dizziness on 02Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events injection site pain, chills, fever, swollen lymph nodes on her neck, dizziness, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day were recovered and other events were recovering.

Tingling around lips in addition to being light headed. Tingling around lips began within an hour and has lasted for more than 24 hours. Skin on lower face has also been itchy (chin, cheeks). This developed later in the day and has persisted for more than 24 hours. Feels similar to when I had a reaction to Niacin.

Dizzy, headache. Left chest pressure. Said she has an appointment with cardiologist this week. She was seen in Emergency room last week with same complaint and was told it was bone or muscle, not heart. All symptoms resolved when she left.

Immediate taste in mouth. Rash on neck and face. Slight throat swelling, slight difficulty swallowing. Very faint dizziness, fatigue.

I had a migraine the day after the vaccine, then on Wednesday, I had knee pain. I took steroids that night but I couldn't hardly slee because of the pain. I had to call out because I could hardly walk. Steroid dose was for 9 days and after wards it resolved.

Guest received first dose of Pfizer Vaccine. While in the Observation Area she reported - Metallic Taste, Left arm tingling, cold feeling, and light ? headedness.? Vital signs assessed. Discussed symptoms and guest reported improvement within two to three minutes. VS: B/P: 150/72, P ? 71, SPO2 ? 100% R/A. Interventions: Water, snack, observed for 30 minutes. Guest reports no further symptoms upon departure.

When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours. I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.

Next morning (7am) sweating, nauseous, blurred and double vision, and dizziness Went back to bed for about 2 hours and woke up with slight dizziness. Sweats and nausea were gone

joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who stated the symptoms are "normal", clarified if she mentioned the dizziness & heaviness to chest, reported she did and her pcp stated it was again "normal". informed her those reported symptoms should be checked in the ED for potential cardiac events. Caller verbalized understanding.

Patient complain of feeling dizzy an d nauseous. EMS on site came over and assess patient, took her vital signs. B/P 118/77, P84, R 18, Oxygen 98% on room air. Patient refused transport to the hospital. EMS monitor patient for 15 minutes, then she stated she felt better and wanted to leave, she was instructed to wait in observation for another 15 minutes.

Brain fog (forgetfulness, wondering what I needed to do), unsteadiness when walking and on stairs; normally walk quickly and on stairs, vision was off a bit more. Reactions started 12 hrs. after receiving shot and the 2nd day. 3rd day was fine.

racing heart.. dizziness.. felt like she was going to pass out said tongue was swelling and hard to breath

Pt reported that the day after her vaccine, she was having severe dizziness, she went to see her doctor who prescribed Meclizine. She took one dose, then the next day had fatigue and dizziness for the next three days. She is now doing fine.

I have been experiencing dizziness/vertigo and mild nausea since the day I received the vaccine. It has not gotten better or worse. Just through out the day it comes and goes.

Shortly after sitting down after vaccination, felt as body was exploding, either from sudden drop or sudden rise in blood pressure. Then severe vertigo set in, everything started spinning and nausea set in. Waited for 30 minutes and vertigo was better, but not totally gone, but nausea was still there. Left facility and nausea abated after 1.5 hours. Vertigo continued for 48 hours but fairly mild. Caused me to walk like a drunk person but no dizziness any more. Then at 10:30 PM torso broke out in hives that lasted about one hour. No hives on arms and legs.

vertigo, double vision, headache, inability to stand. Went to ER, given meclizine and lorazapam. Symptoms improved over 6 hours but, other than headache, have never disappeared completely

Severe headaches, tiredness, fatigue, difficulty walking w/o assistance, lightheadedness, hallucinations that disappeared 3 nights after the vaccination.

Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating really hard/pounding chest; Weakness; Fast heartbeat/Pounding chest; Lightheadedness; Insomnia; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 10Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient reported). A 63-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 at unspecified route in left arm on 08Mar2021 11:30 as a single dose (at the age of 63 years) at for COVID-19 immunisation. Medical history included iodine allergy from an unknown date and unknown if ongoing severe allergy , drug hypersensitivity from an unknown date and unknown if ongoing severe allergy , dysphagia from an unknown date and unknown if ongoing , ongoing Sjogren's syndrome diagnosed 33 years ago , ongoing systemic lupus erythematosus diagnosed 3 years ago , ongoing headache , ongoing intervertebral disc degeneration diagnosed with this about 15 years ago , ongoing fibromyalgia diagnosed 10 years ago , Meniere's disease from an unknown date and unknown if ongoing , supplementation therapy from an unknown date and unknown if ongoing Vitamin c (Verbatim): recommended by dentist bone health and teeth. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for supplementation therapy from 2020 and ongoing; vitamin d3 (VITAMIN D3) taken for hypovitaminosis from 2019 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for hypovitaminosis from Apr2020 and ongoing; timolol (TIMOLOL) taken for glaucoma from 2011 and ongoing; alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for dyspepsia from an unspecified start date and ongoing; cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) taken for fibromyalgia from an unspecified start date and ongoing; cetirizine hydrochloride (GENERIC ZYRTEC) taken for hypersensitivity from 2011 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; olanzapine (OLANZAPINE) taken for bipolar disorder from an unspecified start date and ongoing; docusate sodium (COLACE) taken for constipation from an unspecified start date and ongoing; lactulose (GENERLAC) taken for constipation from 2018 and ongoing; acetaminophen (TYLENOL GENERIC) taken for headache, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; tramadol (TRAMADOL) taken for intervertebral disc degeneration, headache from Dec2020 and ongoing; triamcinolone diacetate (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) taken for rash from 2018 and ongoing; meclizine hydrochloride (MECLIZINE HYDROCHLORIDE) taken for dizziness, start and stop date were not reported. The patient experienced heart was racing, her heart was beating really hard/pounding chest on 08Mar2021 with outcome of recovered , pale and shaky on 09Mar2021 with outcome of recovered weakness on 08Mar2021 with outcome of recovered , fast heartbeat/pounding chest on 08Mar2021 with outcome of recovered , lightheadedness on 08Mar2021 with outcome of recovered , insomnia on 08Mar2021 with outcome of unknown , blood pressure bottomed out on 09Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 'bottomed out' on unspecified date 09Mar2021, heart rate: 95, heart rate: 98-101, heart rate: fast. Therapeutic measures were taken as a result of , insomnia. No vaccines administered on same date with the Pfizer vaccine. No vaccinations within four weeks prior to the first administration date. No ER visit or physician office visit reported.

Pt presented today for 1st Pfizer mRNA COVID vaccine. She received the vaccine at 11:06am and proceeded to the check out area and scheduled her second appointment and checked out at 11:10am. She was sitting in the secondary seating area, she looked scared, then she indicated to the APP she felt dizzy, eyes fluttered back, and slumped back into the chair and into APP's arms. With the assistance of another RN, we laid her down on the ground and lifted her legs. She was arousable to sternal rub and complained of dizziness. She was able to report her name and that her husband was outside in the car waiting for her, however, she was slow to answer questions and still appeared distressed. We made several attempts to obtain a BP, however, it would not register on machine, O2 sat 100%, HR 42, manual HR 50 at pericordium. Her bilateral upper extremities were cool to touch and appeared mottled. We attempted to give her apple juice just she was only able to take a few sips. We placed her on 100% non-rebreather. Given low HR, unable to obtain BP, and semi-conscious state, we elected to call 911 at 11:30am. Her husband was retrieved and at patient side when EMS responded. He reported that she has fainted in the past with blood draws and has a past medical history of "leaky valve, low platelets" and later it discovered via her medical records that she has a history of seizures and was on vimpat and lisinoril. EMS arrived, assessed the patient, and moved her to stretcher and transported patient at 11:39am.

Extreme thirst, chills, full body muscle aches, dizziness, extreme fatigue (so much so I could barely keep my eyes open when driving after 8 hours of sleep the night before), nausea, stomach upset. Note: I have not had a flu shot for 25 years, nor have I ever had the flu during that time, but the symptoms do seem flu like. It is now end of day 2 following the 2nd dose of vaccine and I still feel incredibly icky.

2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by severe pain in muscles "all over her body". She had severe headache. She had a fever of 101.9. She had no appetite and "could not eat" . She remained in bed, barely able to walk to the bathroom for 7-8 days. She was "so weak", could not get up. She did not have solid food for 1 week and was not able to take more than sips of liquid. She has continued weakness fever. Now 3 wks following the vaccine, her temp is 100.2.

fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barely move it or sleep on it, tired feels like a mild flu

patient become diaphoretic and felt like she was going to pass out. pt wheelchaired to bed bp 100/64. pt never lost consciousness. bp came up to 126/74. pt called husband to come in and drank 2 apple juices. EMS requested at 1615. patient then stated she felt woozy and became diaphoretic again. repeat bp 85/56. it later increased to 109/68, sat 97, hr 82. pt also incontinent

I began to experience very painful nerve pain in my body, most noticeable in my feet area making it painful to walk. I had been exercising and after the Pfizer covid vaccine shot, it hurt too much to exercise.

After adminstaration of medication, patient had light headedness, nervousness, anxiety induced symptoms. Paramedic came and took vitals signs and ekg vital signs are stable . As her smptoms dessipate she was release by the nurse.

Muscle ache in both power legs. Bottom and top of right foot extremely painful to walk. Bottom left side of left foot extremely painful. Calves muscles on right leg extremely tight. Top of right foot extremely tight and painful.

0925 pt reported feeling dizzy and lightheaded with blurry vision while sitting for 15 minute post observation time. transported via wheelchair to observation area and placed on gurney in trendelenburg position. 0930 BP 156/84 P 121 pox 96%. 0945 pt reports feeling "better" BP141/73 P 103 , placed in supine position. 0950 placed HOB at 45 degree angle with pt reports feeling "well". BP 167/83 P 83. 0956 pt report feeling "heavy headed and vaccine arm tingly" . Drank 3 oz water. Pt reports being T2 diabetic on metformin. did not check BS this am, but ate breakfast as routine. Reports not regularly checking BS with breakfast. Primary care provider called and spoke with pt. at clinic. PCP advised pt to return to home and self monitor and contact their office if not feeling well today. Husband present and verbalized understanding along with pt of PCP instruction . PT reports BP is occasionally high when anxious. 1010 Pt sitting in chair and feeling well w/o furthur c/o dizziness or blurry vision or heavy headedness . States "feeling good to leave". BP 165/81 P 85 pox 96%. Pt left on foot with husband.

Patient is a 63 yr/o female who presents to the emergency department complaining of dizziness since 0400 this morning. She endorses nausea, vomiting, and headache. Her symptoms are worse with position changes. She states that she has a hx of vertigo with her last episode being 11 months ago. She states that she does not normally have a headache with her episodes of vertigo, but today she developed one. Denies chest pain, sore throat, visual disturbance, or diarrhea. She reports chronic shortness of breath. She is a former smoker. Denies alcohol use. No other complaints at this time.

Patient recieved the vaccine and her husband stated his wife didnt "no where" she was and was confussed & dizzy. Patient appeared diapheretic. Onsite EMS was called at 2:42pm HR 64 BP 76/47 Blood pressure did not recover by 2:58 pm and refused transport to the hospital.

Woke up at 3am on second morning after vaccine with extreme dizziness and nausea. Continued to have dizziness, nausea, and dry heaves until following day. Could do nothing but sleep. Lightheadedness continued through the next day after that but nausea passed.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: clamy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium

Patient felt syncope/fainting. Onsite EMS was called vitals BP 104/66 BG 104 96% O2 HR 64. Patient treated and released against medical advise.

Sore arm for 1/2 day after shot was expected. However, one week after injection (3/39/21), I became dizzy. The next morning (3/30/21), I was extremely dizzy, very nauseous, and had a severe headache. I was hardly able to get out of bed, and unable to work that day. Symptoms lasted until the morning of 3/31/21.

feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; heart rate started pounding; lightheaded and dizzy feeling; shaking all over; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration, administered in arm left on 02Mar2021 12:45 as a single dose (at the age of 63-years-old) for covid-19 immunisation. Medical history included high blood pressure that was treated with metoprolol from an unknown date. The patient had known allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medications included metoprolol succinate taken for high blood pressure, start and stop date were not reported; escitalopram taken for an unspecified indication, start and stop date were not reported. The patient previously took prednisone and ciprofloxacin and experienced drug allergy. At about 25 minutes after receiving the vaccine (02Mar2021 13:15 as reported), the patient had a feeling of extreme warmth or heat in the center of her chest (about where her sternum was). It was a sudden feeling that started radiating outward, seemingly along her arteries and at the same time, her heart rate started pounding, accompanied by a lightheaded and dizzy feeling. The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related. It wasn't a panic attack either. The patient started shaking all over while was driving up and immediately looked for a place to pull over, and began texting someone close by (her brother) to let him know what was happening. No treatment was received for the reported events. The reported events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.

passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pain; temperature of 99.6; flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (Pfizer Brand COVID 19), dose 2 intramuscular, administered in left arm on 26Feb2021 12:00 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination. The patient has no known allergies. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer Brand COVID 19), dose 1 intramuscular, administered in left arm on 05Feb2021 11:30 AM, (Lot Number: EM9810) for COVID-19 immunisation. There was no other vaccine in four weeks. On 27Feb2021 07:45, the patient passed out, unfortunately hit head, felt light headed and slightly nauseous. It was also reported that patient had intense right knee pain, a temperature of 99.6 and flu-like symptoms. The events were also described as follows: 18hrs after the injection, I had intense right knee pain that lasted for 24hrs. Also in that same time period, I felt a huge rush of energy come over me and passed out. Unfortunately hit my head. I had a temperature of 99.6 and flu-like symptoms that lasted 24hrs. For 4 days I felt light headed and slightly nauseous but that could have been due to hitting my head. Called 911, EMT evaluation and the patient received treatment for events. Outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events and other events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.

Client is observed in Observation area x30 min, didn't complain any symptoms. Client went back to her vehicle, and c/o lightheadedness and anxiety. Vital signs taken: BP 119/68, HR 85, SpO2 99%, RA, RR 18/min. Client is provided with hydration and snacks. Client is directed to lay down in her car seat, open the car windows and turned on AC, and observed for another 25 min. Client stated "My energy is back". Client refused 911 services, and stated she could drive home. Client left POD at 10:46am without symptoms.

Heart rate went wild **immediately** upon inoculation. Was wearing a running watch -- rate was 158 and higher. Felt lightheaded, scared as this had **never** happened with a shot before. Pharmacist had me drink water & orange juice, stay there for 45 mins. Heart rate continued to be high for about two hours, but was able to calm it by lying down. Feel uneasy about taxing my heart again with second dose.

When the administer jabbed me with the syringe she hit either my top joint area of the shoulder- left arm/bone or a nerve and I yelped fairly loud and by the time I was driving home (15 minutes) my arm went numb, while sitting at home after about an hour my arm was completely numb and I felt like my entire arm and fingers were not able to stretch out or movement was extremely limited, I could not work my arm up, out or lift it to help myself... the aching was up my neck and down my side... Others within my house saw what was happening...I drank a lot of water and took an ibuprophen. it has been 2 weeks and I still feel some pain, not as intense but if I try to put a sweater or shirt on, my shoulder still has a shooting pain. It's better than the first week, but I will ask to have the next shot in my right arm and hope they inject lower down on my arm, closer to the muscle area. This was a very very bad experience for me.

rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.

3/30-C/o headaches, sinus congestion, injection site pain, nausea & lightheadedness beginning last night. Took ibuprofen with minimal results. Denies SOB, chest pain or difficulty breathing. 3/31-Spoke with pt to follow up with her symptoms. She said that she is doing much better, about 75% back to normal. She still has nasal congestion and drainage. I told her to call back if she had any other concerns for us to document. She thanked me for my call and I wished her a good day.

After the Covid shot, I was instructed to wait in my car for 15 minutes. Approx. 12 min after the shot, I got a burning sensation in my left arm that continued across my upper body, throat and into my bladder and felt like I was going to urinate. It lasted approx. 2 min and subsided. Then I felt like I was going to pass out, so I drank some water and reclined in my seat to rest. I never passed out but waited another 15 minutes to proceed home. As I was driving home approx. 6 minutes since I left the clinic, the same feeling came over me. I immediately pulled off the highway into a near by parking lot until it subsided which was again approx. 2 minutes. I waited 10 minutes then proceeded to drive home which was only. Additional information for Item 18: which was only 5 minutes away. Once home, I laid down because I was tired and uneasy about what had just happened. I had no other symptoms and that feeling never returned. I thought I should call my family doctor and let him know what happened. I called Dr. office and left a message for him about what happened. His nurse called me back and she had relayed the message to Dr., and said I should not receive the 2nd Covid shot since I had this reaction to the first shot. I have not had any other issues except a little soreness in the arm where the shot went in.

3 days after 1st vaccine...tingling in top of scalp my hair follicles hurt 1 week after 1st vaccine...spasms in left leg above knee cap [right hip was replaced in 2010 w/titanium hip] 8 days after 1st vaccine...lower lumbar pain left side 9 days after 1st vaccine...severe pain in upper thigh left side...could not walk...had to lay down for comfort took ib prophen 10-12 days later...left leg ached down to shin 13 days later...went to orthopedic dr...gave me steroid & muscle relaxer & stretches 21 days later...received 2nd vaccine...had to take it prophen for pain relief 26 days later...went to pain Dr wanted an MRI but was declined...continued to stretch Told both Drs about vaccine & nerve reaction but the didn't think it was related. 35 days later...absolutely no pain & can walk and sit normally

Patient DOB 9/6/57 received her first Pfizer Covid vaccine, then became dizzy, "I feel like I am drunk" Patient laid down on an exam table, her husband brought her cookies and water, Patient stated that it had been several hours since she last eaten, left the clinic with her husband as an escort without incident

BP spikes to 164 at night. Still high at night. Taking extra meds for it. Continued nausea, some dizziness, burping, prickly nerve endings with cold sensation. Headache.

She reported feeling dizzy and like she might faint. Blood pressure was 180/100 11:45 tried sitting up and was dizzy blood pressure was 148/88 Ate some food and drank water At 12pm was feeling much better and bp was 138/80 (stated that was her normal range ] She walked out of building and was feeling good

Pt developed lightheadedness, and tingling in tongue and throat. No objective swelling on exam and breath sounds were WNL. BP 140/88, HR 72, SP02 99%. Symptoms improved without intervention. The pt was offered EMS services and ER evaluation but she declined.

It was the pfizer vaccine, got a little tingly and light headed which I am accustomed to. I got very tired but I was able to drive home. At home I fell asleep for an hour or two, swelling started in my legs mostly but also arms and all over. They were swollen like balloons and it was difficult to bend the knee. Swelling was visable, white, no redness, Next day my face was swollen and dark bags under my eyes. I have had this swelling before and another bad episode was after surgery with anesthesia. It is still very tight and sore mostly in my knees. Not sure if it is autommune reaction or allergy.

1st shot was similar, it felt like something popped and my sinuses got crazy, my eyes got watery and swollen, my throat was like a stiff neck, my head hurt so bad i was taking tylenol every 4 hours, at night i got a fever and my husband said i was crying for a blanket, I think I might have gone back to when i was at the hospital, I don't know, we both couldn't walk or move everything hurt so bad. The second shot was worse than the first.

swollen glands plaque in the throat pain in the lower back fever dizziness tiredness nausia poor appetite I didn't go to the doctor because I don't have insurance

Only initial side effect following both injections was moderately sore arm and fatigue. Following 2nd dose I experienced 1 episode of severe vertigo while just sitting doing nothing. Dizziness cleared completely in about 4 minutes. Then on March 13th, was at work, sitting at desk and same thing happened again. After the dizziness cleared I got up and went to see a patient. I work in a rehab unit of a hospital. Got pt approx 50 feet down the hallway when dizziness started coming back. Handed patient over to other staff. I took my blood pressure and checked my blood sugar. Both WNL . Dizziness never got better. Went to ER. They had no clue of cause. All labs were normal. Saw Physical therapist who performed Eply maneuver as well as a ENT. Both got same result. Negative for BPPV. MD gave me Antivert. Didn't work. Are waiting to be seen in May 2021 for NVT test and another with Neurologist. In the meantime the dizziness has remained constant rendering me unable to return to work.

sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weakness; lower abdomen hurt; tired; vomiting; diarrhea; sweaty; little bit of rectal bleeding after diarrhea; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Left upper arm on 24Mar2021 (Batch/Lot number was not reported; Time the Vaccination Was Given was around 15:30) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid, renal disorder from an unknown date and unknown if ongoing , diabetes from an unknown date and unknown if ongoing, blood pressure measurement from an unknown date and unknown if ongoing, vaginal disorder from an unknown date and unknown if ongoing, colitis from an unknown date and unknown if ongoing. Reported following prior vaccinations was stated she had a sore arm sometimes with the flu shot and felt kind of sick but not always. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid from an unspecified start date and ongoing (reported she started taking this decades ago); metformin (METFORMIN) taken for diabetes from an unspecified start date and ongoing ((reported she started taking this decades ago); lisinopril (LISINOPRIL) to protect kidneys with diabetes and for blood pressure, started years ago and took a small dose, stated her blood pressure was usually fine; estradiol (ESTRACE) taken for when the vaginal tissues get disintegrated from an unspecified start date and ongoing (stated she started this a very long time ago). The patient experienced little bit of rectal bleeding after diarrhea on 25Mar2021 with outcome of unknown, sick on an unspecified date with outcome of unknown, tired on 25Mar2021 with outcome of not recovered, vomiting on 25Mar2021 with outcome of unknown, diarrhea on 25Mar2021 with outcome of unknown, sweaty on 25Mar2021 with outcome of unknown, exhausted/wiped out on an unspecified date with outcome of unknown, stomach kind of hurts on 25Mar2021 with outcome of unknown, started to feel lousy on 25Mar2021 with outcome of unknown, tiny bit of dizziness on 25Mar2021 with outcome of not recovered, weakness on 25Mar2021 with outcome of unknown, lower abdomen hurt on 25Mar2021 with outcome of unknown. The event little bit of rectal bleeding after diarrhea considered serious as medically significant. The AEs not require a visit to Emergency Room or Physician Office. Received the first dose of the Pfizer Covid 19 vaccine Wednesday afternoon, yesterday, patient felt okay, but was off, got really sick in the middle of the night. during the day , tired, expected that, but at night vomiting, diarrhea and weak, sweaty, kind of bad. it stopped today she was just exhausted and her stomach kind of hurts. She was better than last night, today she was just more worn out by this, she took a Imodium. She had the vaccine Thursday afternoon and yesterday she felt lousy, nothing severe and last night she was very sick. Stated she was still trying to get better today. Stated she called and left a message with the FDA/CDC vaccine adverse event reporting system a little while ago. Caller clarifies she got the vaccine on Wednesday 24Mar2021 and that she started to feel a little lousy 25Mar2021, more like the symptoms that are described, she was tired and had a tiny bit of dizziness that came and went, it was mostly tired. Stated in the middle of the day she laid down for an hour and that was around lunch time. Stated the dizziness was off and on like when she was driving and just here and there. Stated the tired was still persisting. She stated she did not have NDC, lot, expiry date or dose to provide. Stated she see EUA on the sheet but not much else. Stated it was the 1st dose. Stated she forgot to tell about last night. Stated she woke up around midnight very sick with vomiting and had diarrhea and was sweaty. Stated her stomach hurt and her lower abdomen hurt. Stated she was not sure if these are from the vaccine or a coincidence. Stated she had stopped throwing up, just did that a few times. Stated the diarrhea stopped after a little while. Stated she still has abdominal pain today and weakness was with the diarrhea and she would lay down in bed. Stated she was still a little weak, that she was more wiped out and tired. Caller stated she was bleeding a little bit after the diarrhea and it scared her because a couple years ago she had colitis and it scared her, that she called a relative who is a retired nurse and she thought it was from the diarrhea. Caller clarified she contacted her relative about this current event with the bleeding. Caller provided that she took Imodium this morning and has been sipping on water and had a little breakfast, she thought she may be a little dehydrated. Patient stated her symptoms were pretty bad last night, it was acute. Patient clarified that it was rectal bleeding and it was just a little this morning. Stated it happened last night and again this morning. Stated she was not sure if it was still occurring and hopes it stopped as it it's scary. Stated today she was just resting and trying to get better. Patient said that if it gets worse she will call her doctor and that she had called the hospital last night and they didn't have anything to say. Stated that if it was from the vaccine she was hoping that it's very temporary and went away and be gone if it was from the vaccine. Patient was asking if there was information about the chance that this was related to the vaccine, stated they were not listed as possible side effects. Stated she had people from the hospital and relatives she has talked to that say it may be. Information on the lot/batch number has been requested

12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on 4-7-21, my left leg calf was very sore and hard for me to walk, Got worse, so on 4-9-21 went into Urgent care and through a vascular ultra sound determined I had a very Large blood clot in my calf. (ACUTE THROMBOSIS OF THE LEFT PROXIMAL PERONEAL VEIN)

On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 strokes. I woke up with a throbbing headache and then had difficultly remembering simple things like using the remote control for TV. My vision was also somewhat blurry. I then went to drive and my focus was off making driving difficult so I then went to the emergency room

N17.0 - Acute kidney injury (AKI) with acute tubular necrosis (ATN) W19.XXXA - Fall, initial encounter N39.0 - UTI (urinary tract infection) R73.9 - Hyperglycemia

Felt dizzy 15 minutes after the shot and dizzy throughout the day on Friday, April 9, 2021 On Saturday, April 10, 2021 felt extremely dizzy in morning and passed out in a back room. Fell backwards on the floor and couldn't get up. Was yelling and screaming from the pain. Husband called 911 for an ambulance. I was taken to the Hospital and was admitted to hospital. Was very dizzy. Was not allowed to even get up for 2 days in the hospital because I was considered a serious fall risk. Stayed in hospital until Wed., April 14, 2021 when I was released to go home.

intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up; rush of pressure to back of head and the lower part of head; Headache; dizzy/Dizziness/light headed; out of body experience like floating; my arm started to really hurt/Sore Arm; sore to touch; cloudy and pressure in her ears/Ear Pressure; vertigo issues; vestibular migraines; patient can't walk; tunnel vision; eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 01Apr2021 about 13:30-14:00 pm (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease, Diagnosed 13 Years ago, patient was allergic to penicillin and Avalox (anaphylactic and I am sensitive to medications). Don't know if this happened when she got Hashimoto's, Thyroid, ongoing Vestibular Issues Started 5 years ago. States one doctor thinks it is her bad neck. States when she got old things shifted and changed. One ENT said she has neuritis, where something hit her ear nerve in right ear. States hence that was what the acyclovir was for, when she feels an earache coming on, she takes acyclovir. No previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). AEs following prior vaccinations: None; reported she hadn't had any flu vaccines in years because of the ingredients. States because of her Hashimotos because of everything with her health it was not conducive. Last one was 2014. Concomitant medications included guaifenesin (MUCINEX) taken for hypersensitivity from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine sodium (LEVOXYL) taken for thyroid disorder from an unspecified start date and ongoing; azelastine hydrochloride (AZELASTINE HYDROCHLORIDE) taken for hypersensitivity from an unspecified start date and ongoing; aciclovir (ACYCLOVIR ACTAVIS) taken for ear pain from Mar2021 to an unspecified stop date; naltrexone (NALTREXONE) taken for autoimmune thyroiditis from an unspecified start date and ongoing; alprazolam (XANAX) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; curcumin (TURMERIC MERIVA) taken for an unspecified indication from an unspecified start date and ongoing; 7-keto-dehydroepiandrosterone (7 KETO DHEA) taken for an unspecified indication, start and stop date were not reported; ferritin (FERRITIN) taken for an unspecified indication from an unspecified start date and ongoing; boric acid, zinc sulfate (OPTIZINC) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; lactobacillus reuteri (PROBIOTICA) taken for an unspecified indication from an unspecified start date and ongoing; calcium saccharate (CALCIUM D GLUCARATE) taken for an unspecified indication from an unspecified start date and ongoing; berberine hydrochloride, coptis chinensis, glycyrrhiza uralensis, mahonia aquifolium, phellodendron chinense, rheum officinale, scutellaria baicalensis, zingiber officinale (CANDIBACTIN BR) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication from an unspecified start date and ongoing; alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) taken for an unspecified indication from an unspecified start date and ongoing; pancreatin enzymatic hydrolysate (PANCREATIN ENZYMATIC HYDROLYSATE) taken for an unspecified indication from an unspecified start date and ongoing; levoglutamide (L GLUTAMINE) taken for an unspecified indication from an unspecified start date and ongoing; betaine hcl (BETAINE HCL) taken for an unspecified indication, start and stop date were not reported, Bio Identical Hormone Cream taken for an unspecified indication, start and stop date were not reported. On 01APR2021, she could feel rush of pressure to back of head, tunnel vision, cloudy and pressure in her ears and was dizzy. Hx of Hashimoto's - autoimmune disorder, vestibular issue, concerns with getting the second one (dose). Read about adverse reactions and dizziness was on the list of severe reactions. The instant, within a minute, patient could feel this happening to her, she instantly could feel she becoming dizzy, light headed, out of body experience like floating. (didn't mention this in report) felt like walking on air. While sitting and chit chatting with other people to distract myself. Patient didn't have any anxiety. She will admit she was reluctant to get the vaccine because of my health problems. She was more concerned, she instantly got a headache with the pressure, when she was leaving, she felt her eyes feel weird, almost like an allergy issue, burning, not quite burning either. Kind of like a burning, not quite like a burning, felt like when you walk into the wind that has lots of pollen, that feeling. She didn't walk out side, she was inside when this happened, the pressure was already starting, no headache in front of head, it was in back of my skull, at top of her neck and pressure within the ears and ache and pressure on back of her head. Not dizzy, not like when you are in the hospital and they give she something and patient can't walk, or where you tried to stand and you couldn't , it was more like light headed, like walking on air like. It lasted all yesterday. As the night progressed by 10PM or 11PM her arm started to really hurt, patient took Tylenol and went to bed, took Xanax as she did and slept, woke up fine. This morning it felt like she wanted to have a headache but haven't had it since. It's almost like patient had intracranial pressure, because she had these conditions, so she read a lot. Investigation Assessment was No. States she is calling to report a potentially strange side effect. She states as soon as she got the injection, approximately within one-two minutes, she could feel a rush to the back of her head and the lower part of her head which then made her feel like she had somewhat of her vision clouded, like a tunnel vision. Clarifies her vision was clouded on the sides but she could see forward. Caller states that she was not dizzy like falling over and she does have vestibular migraines and vertigo issues, but she had that feeling of dizziness and when she got up and walked, it felt like she was walking on a cloud. Clarifies she felt a heavy pressure in the back of her head. States as soon as the injection was over, she could feel it. States she is concerned regarding the second dose because of her autoimmune and vestibular conditions. She states is caused immediate pressure in her ears. States that could've affected her and put her into a migraine, she doesn't know. States a friend said jeez you should report that and she read more on the list of side effects and saw something about an allergic reaction and dizziness, and she did have some sort of adverse reaction. States she doesn't know and it is concerning to her. States she is doing fine today, other than a little headache that comes and comes. States it was bizarre with the clouded, not cloudy, but tunnel vision. States she does not want to release any medical records; she declines for now to provide. She states CVS administered it, not her doctor. States she is going to discuss it with him. States she doesn't want to have a worse reaction with the second dose. Caller states a headache is a headache but the pressure she felt within one minute and continuing it concerns her on the second one with the larger dose. States she is also concerned with the second dose if dizziness is a severe allergic reaction, not saying she fell over and wiped out. Patient wondering if that was an allergic reaction. States as the evening went on and she took Tylenol, it improved. States the dizziness improved as the night went on but had a bizarre feeling when she went to bed. States her arm was sore in the evening and is still sore to the touch. Clarifies that her eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something. States it was not like a tired and burning feeling, states she can't explain it but something felt like had an allergy type situation if she has a problem with seasonal allergies. Treatment included took Tylenol. States when someone has an autoimmune issue they have a lot of issues regarding the stomach and take a lot of vitamins and supplements. Caller states she wants to report she has a lot of food sensitivities and environmental sensitivities because of her Hashimotos. States anything can set off an immune response. States what happens with that is she would get on her face, angioedema near her ears and the gland secretes and the passage way swells up. States she takes Pepcid AC to treat it. States this did not happen with her first vaccine. States she was very hesitant on taking the vaccine because knows she has these issues and she didn't want to have adverse reactions. States that her reaction to the first vaccine potentially concerns her for the second dose. States going to speak with the medical information department is a good idea. States the location she received her vaccine was very busy. States they did a nice and good job on getting people in. States the girl administering it did good, but she didn't mention unless you knew you had to wait 15 minutes due to possible adverse reactions, they didn't really check on people. States she just had to do whatever and she didn't know whether or not to report it then because she was not in distress. States she thought she just has to get home and drove 30 miles. All events (AEs) did not require a visit to Emergency Room nor Physician Office. The events of Tunnel vision, rush of pressure to back of head and the lower part of head, Headache, dizzy/Dizziness/light headed, cloudy and pressure in her ears/Ear Pressure, was recovered on 01Apr2021, of my arm started to really hurt/Sore Arm; sore to touch was not recovered, of other events was unknown.

Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient). A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history. No follow up needed. No further information is excepted.

Pt had fever, dizziness, syncope, hypomagnesemia, hypophosphatemia, elevated LFTs and eosinophilia 24 hours after second dose of pfizer vaccine. Admitted to hospital. Treated with abx for possible pneumonia (although clinically pt did not have pneumonia - no cough, no shortness of breath, no hypoxia).

Suffered 2 major/large strokes in her occipital lobes and small temporal stroke She is now blind, unable to walk, sit, stand, eat by herself, and has speech issues. She is needing full care at this time and unknown what future holds She has been in ICU since 4/17 as we found her unconscious 4/17-she was down by herself tor over 24 hours

Vertigo; nausea; headache; swollen glands; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration on 21Mar2021 at 14:30 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high cholesterol and allergic to plants and pollen. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included simvastatin, thyroid (ARMOUR THYROID), progesterone, and estradiol from unknown dates for unknown indications. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) and montelukast (SINGULAIR) from unknown dates and experienced allergy. On 22Mar2021 at 16:45 the patient experienced vertigo, nausea, headache, swollen glands, and fatigue. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of vertigo, nausea, headache, swollen glands, and fatigue were recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow up attempts are needed. No further information is expected.

Took Phizer Covid vaccine Two hours after had bad dizzy spell , then another before bed. Woke up with severe lightheadedness then about two hours felt like i was gonna pass out blood pressure extremely high . Went to ER this lasted for about 2 hours, had to get meds fir dizziness. Still having dizzy spells and cant find cause. Have been to allergist and ENT doctor many test

Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she cannot write or type; arm was sore; she sounded different; they said her speech sounded slurred; was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4; was not able to walk at first; her arm was cold; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 24Feb2021 08:00 (at the age of 63-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included high blood pressure that was diagnosed 2-3 years ago, diabetes; she was prediabetic, heart;cholesterol has been high for about 30 years; since she was in her 30s; all from an unknown date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 02Feb2021 (at the age of 63-years-old) for covid-19 immunization. The patient had no prior vaccination in four weeks. Concomitant medications included rosuvastatin taken for blood cholesterol and takes 20mg once a day prior to stroke and in the hospital they increased it to 40mg once a day and ongoing; ramipril taken for blood pressure and she was prescribed with this medication for a while prior to her stroke. It was discontinued in the hospital. Stated that she did not take it everyday because she was allergic to it; and sitagliptin (JANUVIA [SITAGLIPTIN]) taken for diabetes from an unspecified start date and ongoing and stated that she has been taking for quite a while. On 24Feb2021 she had her second shot. She said that everything was fine that morning; that afternoon her arm was sore. Stated she thought nothing of it. That evening she entertained guest. They were saying she sounded different; they said her speech sounded slurred. She had gotten her vaccine at around 08:00. Again, she didn't think anything about her speech. On 25Feb2021, she got up and did some laundry going up and down the steps. Stated that it was difficult because her arm was still sore. She cleaned the house. At around 15:30 she was doing bills and noticed that her writing looked like a baby's scribble. On 26Feb2021, she noticed that her left arm was weak and was told by her doctor to go to the Emergency Room where they told her she had a stroke. She added that it seemed like her arm was cold for a number of weeks. Stated she was the type to wear t-shirts in the winter because she was always hot. During those weeks she was wearing heavy clothes and was under blankets. She was just now starting to feel more like herself and not so cold all the time. The patient was unable to recall time frame when this symptom began. The events did require a visit to emergency room and physician office. The patient was hospitalized for 4 days due to the events from 26Feb2021 to 01Mar2021. During hospitalization, the patient saw a cardiologist, neurologist, her primary care provider, and the hospitalists who all said it was very suspicious that her stroke happened right after her vaccine. Before she got her second vaccine, she was doing embroidery and everything she normally does; nothing was wrong. They did a CAT Scan that showed nothing. Then the MRI of the brain showed a Pontine Stroke on 26Feb2021. Cardiologist put a heart monitor on her and could not find anything. They were looking for A-Fib or something like that when she was on the heart monitor in the hospital; but it never showed anything irregular. She had a loop recorder implanted to monitor her heart and they haven't found anything wrong on it. She had heart tests, carotid artery tests, ultrasound of her heart and nothing was found on those tests. They pretty much told her in the hospital that they couldn't find a reason for her stroke. She kept asking about the vaccine. They did not rule it out as a cause, but they also did not say it was the cause. All the doctors said they could not pin her stroke on the vaccine. They stated it was suspicious and that they had seen 2-3 other patients with a similar situation. One of the doctor's told her he would not rule it out. They did an ultrasound of her carotids and heart and did not find anything on those tests that would have caused her stroke. She was having lasting effects related to her stroke. Her arm was still sore at times, stated it was a different kind of sore and could be related to all the therapy she does now. The lingering effects after stroke was reported as she was not able to walk at first. She's been doing therapy focused on her left side. Stated that her left side was the dominant side and she cannot write or type. She couldn't do the report online due to the difficulty with typing. She wanted to make sure this was reported. The patient has been doing therapy for 7 weeks, twice a day; and stated she likely still has months more of therapy to try and get her left side back to normal. She said that simple daily duties are difficult. The patient also stated that she was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4. She doesn't know what made it go up. Then states she doesn't know if the vaccine made it go up or not. She has a follow up with the neurologist soon. The patient also reported medications she has been taking since her stroke and hospitalization; but not prior to her vaccine which included Amlodipine-Benazepril: 5-20mg once a day and Aspirin: 325mg once a day. The patient stated that stroke and heart problems do not run in her family. The outcome of the events was unknown.

she was dying from the first shot; Nausea; right arm got sore; Migraine headache; got chills shaking bad; got chills shaking bad; muscle aches, even in her fingers; Feet being Ice cold; no energy; dizzy; This is a spontaneous report from a contactable consumer(patient). A 63-year-old female patient received the first dose of BNT162B2 (Lot Number: ER8737, expiration date: 31Jul2021), via an unspecified route of administration in right arm on 13Apr2021(between 10:15 and 10:30) at single dose for covid-19 immunisation. The patient's medical history included COVID in 2020(had the COVID virus about a week and a half before Christmas/had COVID in the past). Concomitant medications included two unspecified medications. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient was calling about the Pfizer COVID shot. The patient stated she received her 1st shot on Tuesday(13Apr2021) and she didn't know if you have had the COVID virus you weren't suppose to take the shot. She stated that she had the COVID virus about a week and a half before Christmas. The patient stated that she went through a vaccine drive thru and after she got the shot, by time she drove around the corner to park her car, she was dizzy. The patient stated that around 8 o'clock Tuesday night, her right arm was so sore, she stated that she got the shot in her right arm because she uses that arm more. The patient stated her arm got real sore, she had a migraine headache, she got chills and was shaking so bad on 13Apr2021. She had never had chills like that before. Her muscles were aching real bad, it was aching even in her fingers, they were hurting on 13Apr2021. The patient stated that the bottoms of her feet were ice cold on 13Apr2021. She had nausea on an unknown date. She stated that she had the same symptoms as when she had COVID, except the lack of taste and smell. The patient stated that she has no energy on 13Apr2021. She says now, she is afraid to get the second shot because she hears it is worse than the first shot. She stated that still today, she has no energy what so ever. The patient stated she thought she was dying from the first shot on an unknown date. She was scared to take the second one. The patient confirmed she got her 1st dose on 13Apr2021. The patient stated the dizziness started 5 minutes after getting the shot. She said she didn't pay much attention to when it stopped but it was probably later on in the afternoon. The patient said that the dizziness was really noticeable when she was sitting in the car. The patient said her arm is still sore. She said that it is not as sore. She said that on Tuesday it hurt to move her arm but now it is just sore to the touch. The patient stated that her headache, last night started easing off and she woke up this morning and it was gone. The patient stated that the chills and shaking are much better but she still gets cold and then she gets warm and then cold again. The patient stated she took Aleve because her head, and it was easing up before she went to bed, she took Aleve for the pain and headache and she woke up and it was gone. She stated that she is a little better but still doesn't have a lot of energy. The patient stated she was on two medications but it's not for COVID. The patient stated the facility gave her paper work, and she filled out the paper work and she told them that she had COVID in the past on the paper work. No Emergency Room or Physician Office visit was required for the events. The outcome of the events "she was dying from the first shot" and "Nausea" was unknown, of the event " dizzy" was recovered on 13Apr2021, of the event " Migraine headache" was recovered on 15Apr2021, of the event " muscle aches, even in her fingers" and "Feet being Ice cold" was recovered on 14Apr2021, of the other events was recovering.

Dizzy; fatigue; chills; aches; fever; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 15Apr2021 at 4:00 PM (Batch/Lot number was not reported) at the age of 63-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included low thyroid and allergies to penicillin, both from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number), dose 1 on 25Mar2021 at 4:00 PM at the age of 63-years-old as a single dose in the left arm for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient experienced dizzy, fatigue, aches, fever and chills on 16Apr2021 at 12:00 PM. The reported adverse events resulted in emergency room/department or urgent care. Treatment received included fluids and test run to rule out any other problems. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab with negative result on 16Apr2021. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Later that night, on 1/27/21, I felt sick, Nausea, muscle soreness. Next day 1/28/21 went to work with headache, couldn't lift my arm up very swollen. Felt sick got worse felt very hot. Temperature of 104, got sent home from work. Took Acetaminophen and 2 cold tablets fever went down to 101.9. Took cough syrup. Went to sleep. got up next norming arm still very swollen, went to work got sent home no fever but still felt bad, achy muscles and arm still swollen. Stayed home in bed whole weekend. Got headache every day including Monday morning when got up to go to work. Headach on Tuesday also. Felt better on Wednesday. Woke up with headache on Thursday. Woke up with a headache on Friday.

On the floor in the store; Whole left side; radial pulse and everything was gone; Freezing, could not get warm; This is spontaneous report from contactable consumer. A 63 years old female patient reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9269) on 05Feb2021 12:30 at right arm for COVID-19 immunization. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed in 2019 and ongoing asthma diagnosed in 2019. Family history included some heart problems and cancer. Concomitant drugs were not provided. She says she waited the 15 minutes after the vaccine and felt fine. She then went to the store. She ended up on the floor at the store, her whole left side; her radial pulse per the Emergency Medical Technicians, was gone. She was freezing and could not get warm. They put warming blankets on her. She had to be taken out of the withheld by ambulance; she thought she was having a stroke. All of her tests at the hospital were negative. They did a MRI and a CT Scan and everything was fine. The time she got her vaccine to the time they had to call the ambulance was about an hour. They symptoms lasted a couple of hours, then they were gone. She states that at that time Pfizer was saying to wait two weeks between the first and second vaccine; because of her event she was told to wait three weeks. States that she missed that vaccine because her son passed away. She didn't know if she has to start over again with the first vaccine; or if she can just go get the second vaccine that she missed. Her experience with the first one was scary; but her tests were all negative. The patient missed her appointment for her second dose of the vaccine and still has not gotten it. The patient stated that the Emergency Room Nurses and Paramedics said she should get the second dose of the vaccine. The Emergency Room doctor told her that he wouldn't get it if he had a reaction like hers. The outcome of the events was recovered on 05Feb2021. No follow-up attempts are needed. No further information is expected.

she ended up on the floor at the store; Whole left side; radial pulse and everything was gone; Whole left side; radial pulse and everything was gone; Freezing, could not get warm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05Feb2021 12:30 (Lot Number: EL9269) 1ST DOSE, single for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) and asthma. There were no concomitant medications. The patient not received prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. The patient reported that she received her first vaccine dose on 05Feb2021 and initially was instructed to get the second dose 2 weeks later. 30 minutes after getting the first dose she experienced a reaction, she thought she was having a stroke and she was transported to the ER for evaluation and found out it wasn't a stroke. Reports that because of her reaction, her ER doctor advised her not to get the second dose. But her primary doctor advised her to get the second dose at 3 weeks instead of 2 weeks after the first. She was planning to get her second dose 3 weeks after the first dose but her son died and she missed her appointment. Since then she has relocated to other state. It was further reported as follows: she waited 15 minutes after the vaccine and felt fine. She then went to the store and ended up on the floor at the store and had to be taken out of the store by ambulance. Her whole left side; her radial pulse per the Emergency Medical Technicians, was gone. She thought she was having a stroke but all of her tests at the hospital were negative. She was freezing and could not get warm. They put warming blankets on her. They did an MRI and a CT Scan and everything was fine. Symptoms lasted a couple of hours, then were gone. Emergency Room Nurses and Paramedics said she should get the second dose of the vaccine. The patient wants to be fully vaccinated. From the time she got her vaccine to the time they had to call the ambulance, it was about an hour. The patient missed her appointment for her second dose of the vaccine and still has not gotten it. Outcome of events recovered on 05Feb2021.

PATIENT DEVELOPED FATIGUE, INANITION, WEAKNESS, WORSENED DYSPEA ABOVER HER BASELINE. WAS ADMITTED TO HOSPITAL FROM 5/5/2021 TO 5/10/2021 AND TREATED FOR COPD EXACERBATION AND DESCRIBES SEVERE WEAKNESS SHE SHOULD NOT LIFT UP HER HEAD OR PICK UP HER LEGS. NOW HAS DIFFICULTY WALKING WITH HER LEGS GIVING WAY. EXAM 5/13/2021 SHOWS WEEZES ANTERIORLY , DIFFUSE ECCHYMOSES AT PHLEBOTOMY AND CUFF SIZES AND DIFFUSE HEMOSIDERIN VENOUS STASIS CHANGES LEGS AND 1/2 PT BILATERALLY.

SHORTLY AFTER VACCINATION, DEVELOPED DIZZINESS, BILATERAL ARMS THAT FEEL "HEAVY". RECEIVED 25MG DIPHENHYDRDAMINE BY MOUTH. RESOLVED IN ABOUT 1 HOUR

Dizziness, HYPERglycemia, Hx. DM c/o dizziness. Hs. DM. Accucheck was 345. took her sliding scale insulin and said she would take her BP med when she got home. BP 193/83, P. 60, O2sat 100%.

Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and pains. Slight dizziness. The next day, all symptoms gone. Injection site/sore arm for 3 days.

Dizziness, HYPERtension & Tachycardia Narrative: 5 min after vaccine administered L arm felt dizzy. 170/100, HR 133, 97% RA at 1220. Reported poor sleep and mild anxiety. 115/76, HR 116, 96% RA at 1234. At 1237 denies any dizziness or other adverse effects.

Dizziness Narrative: Employee had waited her 15 minutes and left the room. Came back to room and stated she felt dizzy. Vital signs taken and stable. Pt taken to ER for further evaluation.

20 min after injection; BP 192/112, hot flushing, dizziness, blurred Lt eye. Hypertension continued for 1.5 hrs, however hot flush, dizziness and blurred vision Lt eye resolved.

Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain

10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hips & legs. Couldnt stand up. 24hs Later symptoms gone.

Felt slightly dizzy right after getting vaccine and felt an ?adrenalin rush? but these symptoms resolved after about 9 minutes. Then was preparing to leave the observation area at about 1030 her ears started ringing. Ringing is constant and prominent. It so far is not getting any better.

Arm pain; Nausea; lightheadedness; This is a spontaneous report from a contactable healthcare professional (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm in Jan2021 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypothyroidism. It was reported that the patient had allergies with sulfa and trimethoprim / sulfamethoxazole (BACTRIM). Concomitant medications included levothyroxine sodium (SYNTHYROID), ergocalciferol (VIT D), levocetirizine dihydrochloride (XYZAL). It was stated that the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. In Jan2021, the patient experienced arm pain after 10 hours of getting the vaccine. It was also reported that nausea and lightheadedness the following day. No treatment received for the adverse events. The patient recovered from the events in Jan2021 (reported as feeling passed after 2hrs) Information on the lot/batch number has been requested.

Systemic: Dizziness. Patient sat for 45 mins after vaccine. Agreed to oral benadryl 25mg. Felt better within 10 minutes. Issue resolved

Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift

burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizziness; fast heartbeat; tiredness; Had a hard time swallowing at night from the dryness; bitter taste; her mouth went completely dry; patient received 0.45 mL, single dose (225mcg) of PFIZER-BIONTECH COVID-19 VACCINE; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 23Dec2020 15:00 at 0.45 mL, single dose (225mcg) at left arm to prevent COVID. Medical history included a bout of dry mouth about 7 years ago, no other relevant medical history (including any illness at time of vaccination). The patient's concomitant medications were not reported. There's no adverse events following prior vaccinations. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. From the time she got the vaccine her mouth went completely dry on 23Dec2020 and she kept thinking it would go away and she still had it. Event was reported as serious per medically significant. Had a hard time swallowing at night from the dryness. Patient had the bitter taste was also on 23Dec2020, but it went away. It lasted about 5-6 hours. Then after that the dry mouth started right after. It is tolerable but she still had it. Mentioned she had a bout of dry mouth about 7 years ago and it did go away, but she never got a diagnosis for it. Patient thought that something underlying may have triggered it again. Patient also experienced burning of the tongue, tiredness, headaches, pressure in the chest area similar to difficulty in breathing, nausea, dizziness, and a fast heartbeat on unspecified date. Outcome of event dry mouth was not recovered, outcome of event bitter taste was recovered on unspecified date in Dec2020, outcome of other events was unknown. No family medical history relevant to adverse events. No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Relatedness of Pfizer BioNTech Covid-19 vaccine with dry mouth and bitter taste per primary source reporter with method of assessment of global Introspection was related. Reporter seriousness for event bitter taste was not serious.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of dry mouth cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient received the vaccine at 8:01 and at 8:10 patient felt lightheaded (like she was going to pass out.) Patient was given ice packs and continued to feel same. Patient was lowered to the floor (BP 79/55, HR 83, O2 sat 98%). Patient felt much better supine. with legs elevated BP 110/69. Patient feeling much better and was put sitting in chair. BP 122/81. Felt much better, did not want to go to ED. Patient given juice and snack. Pt stated she felt fine. Time increased for observation. at 8:40 patient began to feel lightheaded again. Lowered to floor, BP 78/58 HR 65 o2sat 98%. Patient stated felt fine. Rapid response called and patient transferred to Emergency Department. BP 98/72, HR 71, O2sat 100%.

Approx. 10-12 post immunization, pt. reports dizziness and nausea. She refused to lay down, remained in wheelchair. She asked for cola, it helped settle stomach. As dizziness subsided she had HA. We observed her for an additional 30 min. until dizziness gone. She still had some nausea & HA. Hx: migraines. (She often feels dizzy/nausea prior to migraines)

Vaccine recipient c/o near syncope to RN monitor in the vaccination clinic. Cool, pale, dry skin. She placed her head on the table and asked for help. RN monitor requested assistance. Patient had strong pulse, no respiratory difficulties, no hives noted but was unable to stand. ED Charge nurse notified and ED RN transported patient to the ED via gurney without incident.

bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.

c/o arm tingling after injection, 78-16-114/76 98% RA 1c/o R ear fullness, denies dizziness-A&Ox3, 77-18-120/7 ; full ROM noted-provided ginger ale 1016 78-18-112/61-97% RA R arm continues with "hot wire on 1/2 of Right forearm, continues feeling dizzy but not worse, using Zailo patch for pain control x 2 weeks; at 10:22, 74-18-110/59-98% A&Ox3, Right ear fullness/dizziness improving ; at 10:32 71-18-119/63-99% reports decreased ear fullness dizziness, more normal feeling on RFA, full ROM; @ 10:41, 71-18-102/56-98% denies dizziness or arm burning, ear fullness gone, no n/v

Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving dose, felt extreme coldness from shoulder to tips of fingers for about 30 mins and then resolved. Then afterwards, started to develop redness/itching/hives on back. Patient also felt very lightheaded and blood pressure taken and elevated at 188/84. (20-25 mins after injection). Injection site did swell and got red after. Also had mild HA after arriving home but didn't last long & nauseous feeling the whole day after getting vaccine. Patient did not take any medications and all symptoms resolved on own.

Inflammatory pain; Little dizziness/Light headedness; Fatigue; Arthritis pain in hip, in hand and in wrist; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer's COVID Vaccine; lot number: EL1284; expiration date: 30Apr2021), via an unspecified route of administration left upper arm on Jan2021 at a single dose for covid-19 immunization. Medical history included lupus. There were no concomitant medications. The patient reported that she got her first dose of the COVID Vaccine 2 weeks ago today (Jan2021), and this is her second dose next Saturday. She was a non-medicated, non-kind of remission level of lupus. She mentioned that she was okay the second day, she thinks. She had a little dizziness, fatigue and light headedness that kind of thing. But the top 3 or 4 days ago, so like on her 8th or 9th day, she started to get like inflammatory symptoms like arthritis pain in her hip, in her hand, in her wrist. It was also reported that the patient experienced inflammatory pain on an unspecified date. So, she was just wondering if there are any reports of people with lupus and if the other people have reported that. She mentioned that she wanted to get the second dose but was a little concerned if those arthritis symptoms are going to be worse. No treatment was received. The causality was reported as yes. The patient she hasn't gone visit any emergency room/ physician's office for the adverse events. The outcome of the events was unknown.

Patient received Covid 19 vaccine at 4:00 PM. She has a history anaphylactic reaction from a bee sting. She was advised to wait in observation area for 30 minutes after receiving vaccine. After 20 minutes she complained of being light headed and dizzy. She was given apple juice to drink. Declined crackers. States she ate lunch about 2 hours ago. 4:39 PM VS taken by personnel. BP 126/73, HR 58, pulse ox 100%, Blood sugar 101. 16:45 PM BP seated 110/65, HR 62, 16:46 BP standing 113/60 HR 58. 16:50 PM. Patient states she is feeling better and is fine to drive a short distance home. Advised to return if she has any dizziness while leaving the building. Lead RN, was consulted regarding this patient.

abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore; nausea; GI problems; This is a spontaneous report from contactable consumer (patient). This 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0142), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included ongoing evolocumab (REPATHA, Expiration Date: 04Nov2021), ongoing amlodipine besilate (NORVASC, Strength: 10 mg) as high blood pressure medication, and ongoing amlodipine (Strength: 5 mg) as high blood pressure medication. The patient previously took first dose of BNT162B2 (Lot number: EJ1685) for COVID-19 immunisation. On 12Jan2021, patient got the second dose of the Pfizer COVID vaccine. She did fine all day, but then she started to feel a little nauseous off and on. Then at 4 o'clock before she left for work she developed muscle ache on 12Jan2021. It persisted to the point she could hardly walk this morning (13Jan2021). Patient has not had a fever. She hasn't really had a headache. It has just been muscle aches. Her arm was a little sore on 12Jan2021 but not bad. She has had muscle ache and GI problems with it. She had waves of nausea like she could throw up. She was hydrating really well. The nausea came and went. The muscle aches started at 3:30 to 4 with muscles aching. She got the vaccine to help prevent the spread of COVID and to protect herself as well. Patient experienced abdominal cramping and diarrhoea on 13Jan2021. Outcome of nausea and arm was a little sore was recovering, outcome of muscle ache, abdominal cramping and diarrhea was not recovered, outcome of other events was unknown.

HR 80, 98 SPO2 on RA, 170/98 , 2 160/92, 99 % RA HR 98, 99 % HR 88, 160/90 Pt states she feels dizzy, denies pain at the site. Says she does have DMII and HTN. Ambulated to restroom with RN, given bottle of water, states she has not eaten all day, states she feels anxious and vision is blurry. Pt denies headache, weakness, pain, nausea. Patient verbalized understanding to f/u with 911 or ED with any further problems. Pt also signed hardcopy.

COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20mg of famotidine was administered around 1410. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3mg of epinephrine was administered at 1420. EMS was called. Breathing improved. Pulse ox 100%, HR 68, BP 130/89. EMS arrived and assumed patient care. Pt seen in Emergency Room 1/16/2021 1513 CHIEF COMPLAINT: reaction to COVID vaccine HISTORY OF PRESENT ILLNESS: Patient is a 64y F with PMHx significant for Myopericarditis, Anxiety and HTN who presents to ER after developing tongue swelling, wheezing, tunneled vision and shortness of breath. Patient states that she was getting first shot of COVID19 Pfizer vaccine at 2:00 pm. After getting vaccine she waited 15 minutes like she was told and recalls room getting very hot at approximately 6 minutes after getting vaccine. She also states that her tongue felt swollen. She then noticed her vision started to turn dark and then she felt dizzy. She told pharmacist about symptoms and then she was given one pill of Benadryl. This did not help and actually made her symptoms worse. She recalls wheezing. She was given another pill of what she believes was Benadryl. She also recalls pharmacist measured her BP and her husband, who was present, reported that her blood pressure was in the 140s This did not improve so she was given 0.3mg IM epinephrine shot. This significantly improved her symptoms. However, she was sent to ER. She denies any hx of recent UTI or GI infection. She denies fevers, chills, nausea, diarrhea, chest pain, generalized itching, vomiting, abdominal pain, generalized swelling, headache or syncopal episode. She denies any past reactions to vaccines. She denies current SOB and feels like her symptoms resolved. Denies hx of COPD or asthma. Physical exam did not show any recurrent signs of wheezing or tongue edema. Her SaO2 was 100% on RA and BP was within baseline 140-160s. Given episode, we decided to obtain tryptase levels. We also observe patient to ensure she did not have any recurrence of symptoms. She remained hemodynamically stable and SaO2 remained in mid 90s to 100. She was given a rx for epinephrine pen should symptoms recur though this is highly unlikely as she remained stable throughout ER stay. She was also given instructions to pick up OTC Benadryl and Pepcid. She does have antihistamines listed as an allergy but patient states that she gets tachycardic upon taking tabs, so this could just be a side effect. We will follow up with tryptase levels but even if tryptase levels return as normal, it does not mean she did not have an anaphylactic reaction to vaccine. Her clinical picture puts this diagnosis high in the differential. Teaching and instructions were given to patient and her husband. She was advised to return to ER if symptoms recur. IMPRESSION: Anaphylaxis Anxiety attack

Approximately 19 hours after my second Pfizer vaccine, I experienced dizziness, plus fever and chills. I experienced two bouts of extreme dizziness, within minutes of each other. I did not go to the hospital nor did I call 911. My husband helped me to my bed where I went to bed and slept off and on for over two hours. I felt well enough to eat lunch, then went back to bed, where I slept for three hours. No more episodes of dizziness occurred.

Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am that morning. Intense fatigue and moderate headache. I had joint and body aches. I experienced lightheadedness when I got up when fever was 101.8 at 2:30 pm. I had to lay down again and apply a wet towel. Once I felt able to walk (about 10 minutes later) I ate a popsicle and then proceeded to take two 325 mg of Tylenol. Within 30 to 45 minutes fever subsided. I then ate soup, crackers and an orange and drank cranapple juice. I went back to bed and slept some more. I woke up at 5 pm and had a cup of soup, a quarter of an apple and gatorade. At 9 pm I took two more Tylenol to be safe and when to sleep. Sunday I was fine. My arm, never was swollen only a little sore.

Approx 8 minutes after receiving the vaccine client started c/o feeling pressure behind her eyes. She has had this problem before and thinks it is because her blood pressure is elevated. Client was not feeling well enough to drive home so her husband came and got her. She said after she was home for a few minutes she felt better. She was able to pick her car up within 2 hours of the incident. She did call her PCP and let them know.

Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. Then 11pm Sar night sudden intense pain at inj site spreading rapidly around back of neck and down other arm and up to head. Wracking chills for about 8 hours. Shaking uncontrollably, aches and pains, very weak, exhausted, nauseous. About 8 hours later, 7am Sunday, fever developed, eye pain with severe headache. In bed 30 hours. Monday morning felt much better but still fever @100 and weirdly dizzy. Ate and drank water. Today, almost 72 hours later fever gone, still very dizzy. Drinking water to see if that will help.

Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

at 3:22, Pt waved down (EMT) on site. Clt sitting in vaccination observation area. C/o feeling hot, dizzy, and lightheaded with vasovagal like symptoms. Pt moved to reclined position, and reported immediate relief. Vitals taken at 3:35: BP 132/90, 66 HR. Denies other s/s allergic reaction. Clt sat up 8 min later, states symptoms resolved. Clt completed Vaccine observation period, ambulated self to bathroom and left site at 3:46 pm.

dizziness; severe injection site pain and swelling; severe injection site pain and swelling; swollen neck glands; scattered itching; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 12Jan2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included end-stage renal failure and bipolar and the patient had known allergies to penicillin, sulfa, fish, shellfish, broccoli, and cauliflower. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication included apixaban (ELIQUIS) from an unknown date at an unknown dose for an unknown indication. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 12Jan2021 at 01:15 (as reported) the patient experienced severe injection site pain and swelling, swollen neck glands, scattered itching, and dizziness. The patient was treated for the arm pain with paracetamol (TYLENOL). The clinical outcome of the severe injection site pain and swelling, swollen neck glands, scattered itching, dizziness was recovered on an unknown date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.

WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME ARM AS THE 1ST DOSE. WHILE I DIDNT FEEL THAT SORE IN MY SHOULDER on 2/3 THE FOLLOWING DAY AFTER A HIGH FEVER AND GENERAL/ALL OVER MUSCLE ACHE, CHILLS my left armpit began to hurt like I'd pinched or been punched in it, today my armpit is swollen with a knot under the skin and very sore to the touch and slightest movement (injection site is red and swollen with a knot in that area as well. *my son also received his second shot on same day & he is reporting to me the exact same issue.* icing the area is not helping.

Muscular pain in the shoulder, arm and neck through the evening and following day, enough that it limited my lifting my arm. Further I began feeling extremely itchy on my arms, hands, and face. Checking later in the evening, I did have red blotches all over both arms and shoulders. Took a benadryl and by morning the red blotches were gone as well as the itching.

Vertigo; Ataxia; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 64-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as product COVID 19 vaccine brand Pfizer, lot EL3302), intramuscularly in the left arm on 20Jan2021 10:15 at SINGLE DOSE for Covid-19 vaccination. The patient's medical history was not reported. No known allergies. No Covid prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), naproxen sodium (NAPROSYN), sertraline hydrochloride (ZOLOFT) and esomeprazole sodium (NEXIUM). The patient experienced vertigo and ataxia on 21Jan2021 08:30. No treatment was given. The outcome of events was recovering.

Dizzy Heart Palpitations Shortness of Breath Tingling of Lips & Tongue Swollen Face Head Pain Throat Tightness

shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pain; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient herself). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm), on 20Jan2021 09:00, at single dose, for covid-19 immunization. Medical history included allergies: penicillin, sulfa, environmental. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC ALLERGY); calcium; and colecalciferol (VIT D3). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), on 30Dec2020 16:00, intramuscular (left arm), for covid-19 immunization at 64-years-old. The patient experienced, "10-11 hr" post injection, on 20Jan2021 20:00 started shaking chills lasting 10 hours. The patient also experienced on 20Jan2021 20:00 severe frontal headache with nausea and intermittent dizziness, muscle pain, joint pain, and fatigue - which all resolved after about 24 hr after onset. No treatment was received for these adverse events. The patient recovered from all the events on 21Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination and have not been COVID tested post vaccination.

37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal syncope. Started sweating, and I lost my vision, then must have fallen on the floor. When I came to, felt very headachy and nauseous. went to urgent care - they ordered an abdominal scan for 2/8/21 but scan did not reveal the cause of the pain. 8 hours later on 2/5/21, started feeling asthma like symptoms. Throat felt tight, voice became hoarse, kept having to cough because airway was starting to feel thickened. went to ER, they took vitals and told me that i wasn't having an allergic reaction because my symptoms were outside the time frame for an allergic reaction. After 3 hours there, they sent me home. Next morning felt like I was having heart palpitations. that feeling eventually went away if I walked around. But the following two mornings, I had the same feeling.

Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl most likely contributed to the events as the patient is known allergic to antihistamine tabs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Extremely sore arm intensified 14 hours later when I decided to take Advil. Within a minute I began to weaken, ultimately collapsing on bathroom floor. My husband heard me fall and tended to me. He stated that I was unresponsive for 5-10 seconds. My husband provided me water and allowed me to lie on the floor until I was strong enough for him to assist back to bed. He reported my skin was clammy and moist to the touch. After resting for 15 mins he assisted me to the bathroom to urinate. I returned to bed and slept until 5:30 am when I awoke and went downstairs. I was feeling well enough to go on my weekly 90 minute bike ride at 8:30 am.

fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch, fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )

I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomiting within a couple hours. Around noontime I vomited twice more. I got worse, could not walk around. I felt extremely sick but felt better when I lay down in bed. I was not able to go to work, had to cancel the substitute teaching assignment I had taken. I did sleep some. No doctor called me back except my daughter texted with me. She is an intern, said she wished she could be with me. My neighbor brought some Pedialyte. This morning, the next day, I am still weak and nauseous, but it is less. At the end of the day yesterday, I did eat a little rice with carrots. And I just ate a little plain oatmeal with raisins and salt. I am praying the 2nd dose will not be worse, as my daughter warned, because I can't remember when I was so sick and incapacitated. Maybe a long time ago.

patient was vaccinated at 0801. After 15 minutes patient started feeling light headed and weak. Vital taken. patient was monitored until 0842 with little improvement in symptoms and pulse was low. Patient was transferred to urgent care , and checked in for further evaluation,

Immediately on the day of the vaccine and on the day after the vaccine, I had periods when I felt a little lightheaded but otherwise felt fine except for a little injection site discomfort. Two days after the vaccine I began to feel back and right leg discomfort. By Day 3, the pain in my leg was severe and I started to notice the tell tale signs of Shingles. I immediately contacted my PCP and the shingles diagnosis was given on 2/8/21 due to my symptoms and appearance of my leg. I was immediately put on a 7 day course of Valtrex. On 2/9/21, because the pain was intolerable, I contacted my primary care physician ad was given a 50 mg dose of Lyrica to be taken twice a day.On 2/10/21 the lyrica was increased to 75 Mg dose twice a day since the 50 mg wasn't totally helping. On 2/12/21 the lyrica was ordered for 3 more days and just to be sure there wasn't a herniated disk causing any of the pain, am xray of the thorasic spine was ordered. On 2/17/21, I had an appointment with a pain management physician. He examined me and performed a neurological check and checked the function of my back and confirmed the shingles diagnosis. He continued the Lyrica for 3 months and ordered a Medrol 5 day dose pack. His follow up is in 3 months. He told me not to take Dose 2 of the Covid Vaccine.

extreme muscle pain (first 24 Hours) severe headache (first 24 Hours) Dull headache (Second and Third day) Fatigue (every day) Nausea (first 24 Hours) Dizziness (every day) Took Tylenol on first day, later in the evening, and It really helped

Patient complained of stiffness/right side; headache, dizziness after receiving first dose of Pfizer; Comprehensive nursing assessment done including vital signs, pain, neurological status. Patient stated she had no difficulty swallowing. She was given water. Vital signs remained stable.

I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit. Then I passed out, I fell down and hit my face on the floor. My family called 911 paramedica. They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital. I suspect the incident and its symptom are side effects of the vaccine given the timing. Later on I had headache off and on and brain fog.

In 4 hours, started getting getting very dizzy, then throwing up, and nauseous by 7:30pm felt Luke on worse six flag ride. Blood pressure went up to 166/106. Called 911. Diagnosed with possible reaction and developed TIA

Next day following vaccine - site injection pain (right arm). Arm pain has continued and progressed limiting mobility. In the past 7 days patient has progressively declined in from independent to requiring assistance with walking. Pain and limited mobility in legs

Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, and then completely down for a couple of hours, ending by day 3. Have been constipated for five days now, with no bowel movement since vaccine. I have had extreme insomnia since vaccine.

Within 30-45 minutes after injection, I started to feel a tingling around my jaw area. Then 3 days later I have had several episodes of dizziness, weakness and nausea. This has continued until today (4 days) along with aching across sholders and behind eyes.

Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen after 5 days. Overall itchy, but no rash. Thursday-Saturday diarrhea and lethargy Some intermittent vertigo. Rest, fluids, Tylenol and benedryl

Moderate anaphylactic reaction - according to doctor I consulted afterward. Throat swelled - difficulty breathing and swallowing, weak, dizzy, rapid heart beat - started about 16-17 minutes after the vaccination. Lasted a little over 3 hours. Profound fatigue the next day.

Patient taken to ED by EMS after COVID vaccine. Patient with SOB, dizziness, and HA after first COVID vaccine.

As the needle was being inserted and while the vaccine was being injected, I immediately felt intense pain like none I've had during any prior vaccine administration . The needle was inserted very high on the arm about 1/2 inch below the shoulder. About 4:00 pm that afternoon, new pain developed in the same shoulder, along with very limited range of motion, gradually worsening during next few hours. By 9:00pm the pain was excruciating, like there were multiple knives in all directions in my shoulder. By then I could not lift or move my arm any amount in any direction without excruciating pain. I suspected a severe inflammatory response. This pain level continued for the next 2 days. On the 3rd day the pain was a little less severe and I had slightly more range of motion, but was still unable to lift my arm without pain. On the 4th day (Feb. 18) the pain was a little better but I still had severe sharp pain if I lifted my arm in certain directions. I began to suspect a torn muscle or tendon. Today (March 5, almost 3 weeks after the vaccine), the pain and limited range of motion are the same as Feb. 18. It is relieved only by complete rest of the arm, and easily aggravated by any basic activity (grocery shopping, dressing, etc.) I believe my shoulder was injured by improper administration.

Patient received her first Pfizer vaccine today at 12:24pm .She was sent to observation feeling well. About 10 to15 minutes later she began to complain to her son that her head felt "bloated", her eyes felt heavy and her head felt hot. The nurse removed the patient to the nurses station and took her vital signs, then notified the clinical lead PN. The patient Initial vital signs taken at 13:15 were BP 157/85 P 78 , O2 sat 99%,. R 18. Denies Shortness of breath, difficulty breathing or swallowing. No skin color changes noted. No rash or pruritis. Denies chest pain, pressure or palpitations. Consumed a bottle of water without difficulty. About 20 minutes after the vaccine was received she began to feel faint, but did not feel as though she was "going to pass out" . VS remained stable; BP 157/85/P78.O2sat 99% She continued to c/o head fullness, but now was reporting feeling chills, and flushing . Son administered an extra strength Tylenol at 13:10. Nurse acted as interpreter as well as her son. Paramedics were called initially at 12:56 and again at 13:21 Patient was able to get up and walk to the bathroom with attendants , voided under observation and return to her chair without complaints of instability or dizziness. Paramedics arrived at 13:45. Vs were noted to be 160/90 , pulse 75, O2sat 99% Patient continued to complain of head and eye fullness and vertigo( Paramedic looked like her was swaying). Patient appeared stable ,in no acute distress when she was escorted out of the building ambulance by paramedics at 13:55 to be taken to a Hospital for evaluation.

Huge headache, high fever 103,and chills for two days then lowgrade for 36 hours, dizziness,severe muscle pains, extraordinary fatigue, diarrhea and nausea, swelling feet, weakness

Muscle soreness of bilateral legs and hip joints/ got worse; pelvic pain; Couldn't walk; Drag showed inflamed pelvic girdle; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Solution for injection, lot number: 42 (as reported)), via an unspecified route of administration on the right arm on 15Jan2021 08:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol, fish oil, calcium and monascus purpureus (RED YEAST RICE). The patient had known allergies: DILAUDID. The patient experienced muscle soreness of bilateral legs and hip joints on 22Jan2021 and it got worse. Patient also experienced deep pelvic pain on an unspecified date in Jan2021 and went to physician on 24Jan2021. The patient couldn't walk in Jan2021. Cat scan showed no apparent reason, drag showed inflamed pelvic girdle on Jan2021. The outcome of the events was not recovered.; Sender's Comments: Case serious due to Pelvic inflammatory disease, classified Medically Significant and always serious event, per List Critical Term. Other reported events were non-serious. Based on available information, the Company considered that all reported events were possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness

6 and a half days later felt very dizzy, and today on march 8, I'm still dizzy. Feels like a light case of vertigo.

One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. I was extremely happy that I was NOT driving. I could not think straight and had sweat pouring down my face. My head was very heavy and as the day progressed, my neck also became sore. I took Advil and later Tylenol and they helped the head ache but not the dizziness. I lost appetite. I consulted the reading material about the vaccine and all of my symptoms were normal side effects, so I did not seek medical assistance. My daughter is a doctor and wanted me to report for statistical reasons.

Face turned red, and then numb, hard to breathe, and felt like heart beat quicken, and felt like passing out. Lasted for about 3 minutes.

After receiving her vaccine client stated that she felt light headed, has tingling in both hands and feet.

Evening of 3/8/21 severe dizziness, nausea, vomiting, weakness: lasted several hours then gradually improved overnight

Dizziness/light-headed, feeling like I was about to faint started morning after vaccine along with severe neck pain. Possible intermittent fever. Dizziness continued for 2 days. Neck pain improved somewhat but is still bothering me, woke me up at night. Now a week later and my neck still hurts. I called my primary care office on March 3 and they said call 211. That made no sense so I asked again and they finally said I could see a nurse practitioner the next day. However I didn?t go because I couldn?t drive. I am a little worried about the second dose.

at 1420 pt reports having a runny nose, sweating, feeling hot and having sever lightheadedness. BP=127/85, P=83, T= 99, O2 sat 98%. Appears anxious. Stating "Oh my god. I can't believe I am having a reaction" multiple times. Fanning herself with her vaccine card frequently. Placed in front of a large fan by this RN. Pt states that the wind feels good. has stopped fanning herself. At 1430 reports mild lightheadedness, no sweating and reports she is ready to go . When this RN turned around pt was gone.

Pain and weakness in my right arm. Inability to lift things above shoulder height. Pain when trying to sleep at night. Pain when trying to do certain things at my job with my right arm.

Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, general "dumpiness" ~9 days after: Tender joints in toes, leg pain and weakness, dry, irritated, blurry eyes, brain issues: dizzy, word retrieval issues, derealizing Feb 11: fatigue, muscle weakness and pain in legs Feg 12: headache, heavy feeling in chest, continuing leg pain and weakness. March 12 Pain in legs persists, but improved, brain issues improving, but not resolved, eyes still somewhat dry and blurry/strained

64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt reports got her second covid vaccine on 3/92021 in the left arm, Pfizer. Yesterday (3/10/21) woke up with severe right knee pain, felt like she could not bear weight/ws going to fall. She went to son's apartment who is in same building and then went to lie down in bedroom. Because she drinks a lot of water, she had to get up to go to bathroom to urinate. She was about to sit down on toilet, when she felt both her legs go numb as well as her arms and her vision was blurred. She tried to grab the tub but fell forward on the floor. She states she urinated on the floor. She was on the floor for about 30 mins until her son got her up and back to bed. Later in the day she needed to urinate again and when she got up, she felt unsteady and fell on the bureau bruising the left arm. Since she feels a bit unsteady with gait and used a walker to come hre today. She denies feeling dizzy before her falls. She denies striking her head. She denies convulsions or hx of seizure disorder. She reports no new meds, only recent change an increase in her alprazolam dose. She does report a headache day after her vaccine.'She denies vomiting or diarrhea or antecedent illness. No longer has headache. She denies positional changes Of note she is on propranolol (prescribed by psych) as well as lisinopril-hydrochlorothiazide for HTN 64 yo female with bipolar disorder on multiple psych meds, htn on propranolol 20 mg bid and lisinopril-hydrochlorothiazide, s/p recent Pfizer covid vaccine, s/p presyncope episode after experiencing severe right knee pain and attempted micturition. Pt felt like her sight was affected and experienced numbness/weakness in legs and arms causing a fall. Did not hit head. The history is most suggestive of a vagovagal episode.

Starting Sunday after vaccine, patient started experiencing gut pain and immediately started a liquid diet. In spite of that it progressed. By Tuesday she was not able to walk upright. She went to urgent care and was sent immediately to ER for a CT to r/o possible perforation. Dx was Severe diverticulitis flare requiring antiemetic, pain medication, CT scan at ER antibiotics. She has had flares in the past, but it?s always due to diet and mild. This time she had been compliant with her diet for weeks or months.

Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unable to bear weight, go up stairs without assist or sleep. Next day #3, severe pain in Rt hip, Rt knee and femur. Not responding to Motrin 800mg Q6-8hrs, Tylenol 1gm Q6-8 hours. Day #4 pain now radiating down rt leg through both joints and into Rt calf. Now Monday- called PCP, advised symptoms and would be starting perocets for 2 days of severe pain post vaccine. Also took ASA 325mg for blood clot risk know with virus even through pain was hip to ankle now (not ascending but descending) Percocet Q6hours without improvement but could sit and sleep with pain (dulled brain response to pain). Day #5- leg completely numb, pain now following sciatic nerve, stopped meds as no improvement and developed headaches, stomach aches and constipation from meds. Day#6 Pain severe in am, from hip to ankle- leg and heal of Rt foot numb. Today #7 pain on awaking, Rt hip all along sciatic nerve to foot which remains numb in heel.

the day after my shot i had chest pain that felt like my bones needed to pop and the pectoral muscles were extremely sore and had a hard time lifting both arms due to the pain. Took tylenol and it did not help at all. The intense pain lasted that day and did ease up somewhat the following day but was still sore with a dull achy pain, and today is the 3rd day and still just a little sore in the chest area

After vaccine administration patient started to feel in her left arm knumbness and tingling, and around her mouth and down her legs, patient was removed from the vaccine cell and taken to the observation area, she was placed on a litter and blood pressure 150/86, HR 73 pulse ox 99 and her left wrist. patient was observed and follow up blood pressure was 143/90 HR 75. patient was observed for 15 more minutes . she was then being escorted out to go to her car and she became lightheaded and dizzy and unsteady she was then placed in a wheelchair and taken back to the observation area, her follow up blood pressure was 1 @ 104/70. Patient was placed on the litter in trendelenberg, Follow up BP @ 1341 was 140/83 HR 75 laying, sitting she was 158/98 HR 75, and then after standing for 1 min she was 172/109 HR 75. Patient reported no feelings of lightheaded or dizzy, she was taken in a wheelchair to her car to meet her spouse.

had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned bright red Subsided within hour.; Ate supper, Went to bed, upon waking in nite experienced imbalance; vertigo; Neck pain; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, Solution for injection), via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 vaccination. Medical history included CAD (coronary artery disease), Irregular heart rhythm, BPPV, degenerative disc disease, anxiety, ptsd (post-traumatic stress disorder), pre diabetic, Allergies to food, chemical and sensitivities and med and sensitivites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. Upon receiving injection, on 30Jan2021, patient had flush feeling (much like injection during CT scan). Within hour her ears felt hot and turned bright red Subsided within hour. After supper, went to bed, upon waking in night experienced imbalance. Laying back down experieced vertigo (what she thought was a BPPV episode, a prior cond) but she couldnt figure out which side to treat, she performed maneuver. But did not resolve. She was remaining off balance and spinny even being upright with movement of head or eyes. Neck pain and headache residual nausea. About 12 hours after injection. Upside, her arm doesnt hurt. The patient did not receive any treatment for the events. No seriousness criteria was reported. The patient underwent lab tests and procedures which included computerised tomogram and results are unknown. The outcome of events was unknown.

dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination. The information on the Lot/Batch number has been requested.

3-10-21 2:55PPINK, W/D, RESM PT STATES SHE BECAME 'LIGHTHEADED UPON STANDING UP'. NO N/V, NO SOB/DYSPNEA, NO PAIN. A/O X3, RESP WITH EASE. SIPPING WATER, COMFORT GIVEN. 3:10PM 'FEELS BETTER NOW' AMBULATORY TO EXIT, GAIT BRISK AND STEADY. 3-15-21 10AM 'FEELS BETTER NOW, NO LIGHTHEADEDNESS'.

The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't barely lift legs to walk. No bladder control. Hard to get to bathroom. Fell twice. Second time hitting head. Then, Difficulty breathing. And heart racing. (Please note: I did actually have Covid last summer from July through August).

Tingling, feeling faint, itchy tongue, light headed, blood pressure checks: 09:43am 150/75, 09:45am 100/70 Epipen administered. Blood pressure at 09:48am 130/82 Transported at 09:57

Extreme chills (teeth chattering); low temp (100); fatigue, wheezing and couldn't move my body from my neck to the bottom of my back and "rice" sound in my ears when moved head.

With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rashy red and hot, had the shakes, nauseous dizzy and short of breath, blood pressure was high, with in hour my heart rate started to slow down, I took a Benadryl, felt ill. Tuesday started having diarrhea then around 11:30 pm had same reactions as Monday after shot was given. Took another Benadryl. Wednesday still bouts of diarrhea, tired,weak.nauseous.

Within 15-minutes of vaccination, the patient reported chest tightness and was concerned she was having an asthma attack. EMS evaluated the patient on-site. The patient was hypertensive (150/85). The patient's EKG demonstrated NSR, rate 82bpm, no ST elevations. EMS administered 8L/min O2 and DuoNeb (2.5mgAlbuterol/0.5mgIpratoprium). EMS transported the patient to Emergency Department. In the ED, the patient reported general weakness and feeling mildly lightheaded in orthostatic position. The patient noted feeling better after taking their inhaler and receiving the DuoNeb treatment. Labs were non-actionable. The physician administered 1L normal saline and discharged the patient with diagnoses of Chest tightness, Adverse reaction to vaccine, Asthma, Orthostatic Lightheadedness. Patient was prescribed Albuterol Sulfate on discharge.

As soon as I walk 5 steps from the vaccination station everything became black and I got very dizzy. I sat immediately because I felt I was about to faint. I waited 20 min for the dizziness to diminish and was able to walk by myself. My vision was blurry and felt my eyes were moving rapidly side to side. My husband drove me home because I still fell too dizzy to drive back home. The dizziness continued the day of the 2nd dose administration and got less bothersome if I stayed in bed. The following day the dizziness was much less but I still stayed in bed. Monday March 15 I also experienced dizziness and stayed in bed. Since the first dose on Feb 09, 21 I have felt tired and not always being able to complete my physical therapy routine. The tiredness is not every day. It comes and goes.

After leaving the parking lot of the church, I started to feel dizzy, having hotflashes, weak, and I was experiencing fast heartbeat. I pulled over the car, and then I was shacking. I opened the window to get some fresh air, and drunk water. I could not moved or do anything. I waited in my car for over 20 minutes hoping that I would feel better. I was still feeling weak and shacking. Finally a member of my family came to pick me up. and took me back to the church which was less than one mile. I explained the situation, they told me that they did not have a doctor on premise and to contact my primary care physician or to go to an emergency care facility. I started to shack less. So the member of my family took me back home and I just relaxed while I had chills for two hours.

Immediate tingling of lips and tongue and light headedness. I waited at the vaccination site for 45 minutes. When there was no further progression of clinical signs, I left the vaccination site. No treatment was given. The symptoms lasted for approx. 2 hours.

Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little fatigue; Severe arm/injection site pain; Severe arm/injection site pain/very sore arm; Chills; Low grade fever; Headache; Lightheaded; Weakness/really weak; Itchy rash on chest/has a rash on her chest/little rash on my back; Nausea; Loss of appetite; She is flushed; tested positive for Covid and 6 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: EL9265) in right arm via an unspecified route of administration on 08Feb2021 07:45 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included osteoporosis, Inappropriate sinus tachycardia, known allergies. Concomitant medication included estradiol benzoate (ESTRADIOL [ESTRADIOL BENZOATE]), calcium (CALCIUM), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), naproxen (NAPROXEN), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all at once a day. The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient had the first vaccine on 08Feb (complete date not clarified), two days after that it had most of the side effects, with the one very sore arm, headache, fever chills, nausea, feeling very tired, about 6 days after that she tested positive for Covid and 6 days after the first vaccine. She tested positive for Covid so for the last couple of weeks. She had Covid, the fever broke about 5 to 6 days ago, she had a low grade fever after that, also the symptoms were gone now, there was little fatigue and little rash on back. She was scheduled to take second shot now and was trying to find in research about taking the second shot inspite of having covid. She cant find anything, most of the people never heard this and primary care physician said to go ahead and take the shot, but some people and some researchers said you should not, because she might have symptoms later and she should wait. The treatment was not received for the adverse events. Outcome of tested positive for Covid and 6 days was unknown and for other events it was recovering.

Almost immediately I felt a tightening on the back of my neck. It was familiar to me; I feel exactly that same symptom when I eat something with MSG. Within minutes I felt light headed and exhausted. I went to the pharmacist and he gave me Benadryl; I don't know the exact amount, but it was in the small cup that comes with different kinds of meds. It made no difference, so I had to call my husband to pick me up. I was very, very tired so I slept for the next 3 hours. I went back to bed 2 hours later and slept through the night. I was up the next day and by 11 am was very tired; I slept for 4 hours, then again through the night. By the next day, I felt normal.

post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 minutes-slight drop in blood pressure (I've gone as low as 32/18 during a bad reaction so I know this time was a much smaller drop) 13 minutes-stomach pains started, these would continue throughout the night waking me, and lasted approximately 17 hours 30 minutes- sudden feeling of lightness in my body, and that a light had gone on 60 minutes-odd sensations in throat but did not feel swelling, simultaneously at 60 minutes-dizzy the next day, 10 bowel movements until 2 pm